92 results on '"Shores-Wilson K"'
Search Results
2. The Inventory of Depressive Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation
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TRIVEDI, M. H., RUSH, A. J., IBRAHIM, H. M., CARMODY, T. J., BIGGS, M. M., SUPPES, T., CRISMON, M. L., SHORES-WILSON, K., TOPRAC, M. G., DENNEHY, E. B., WITTE, B., and KASHNER, T. M.
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- 2004
3. Dr. McGrath and Colleagues Reply
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McGRATH, P. J., primary, STEWART, J. W., additional, FAVA, M., additional, TRIVEDI, M. H., additional, WISNIEWSKI, S. R., additional, NIERENBERG, A. A., additional, THASE, M. E., additional, DAVIS, L., additional, BIGGS, M. M., additional, SHORES-WILSON, K., additional, LUTHER, J. F., additional, WARDEN, D., additional, and RUSH, A. J., additional
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- 2007
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4. The Texas Medication Algorithm Project: Clinical Results for Schizophrenia
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Miller, A. L., primary, Crismon, M. L., additional, Rush, A. J., additional, Chiles, J., additional, Kashner, T. M., additional, Toprac, M., additional, Carmody, T., additional, Biggs, M., additional, Shores-Wilson, K., additional, Witte, B., additional, Bow-Thomas, C., additional, Velligan, D. I., additional, Trivedi, M., additional, Suppes, T., additional, and Shon, S., additional
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- 2004
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5. Ethnic/racial comparisons in symptomatology in a large sample of patients with schizophrenia in Texas
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Dassori, A.M., primary, Velligan, D.I., additional, Prihoda, T.J., additional, Miller, A.L., additional, Chiles, J.A., additional, Rush, A.J., additional, Shores-Wilson, K., additional, Biggs, M., additional, and Crismon, M.L., additional
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- 2003
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6. Clinical predictors of cognitive function change in schizophrenia
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Prihoda, T.J., primary, Miller, A.L., additional, Velligan, D., additional, Bow-Thomas, C., additional, Biggs, M., additional, Shores-Wilson, K., additional, Carmody, T., additional, Crismon, L., additional, and Rush, A.J., additional
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- 2003
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7. Feasibility trial of the schizophrenia algorithm in TMAP
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Miller, A.L., primary, Chiles, J.A., additional, Shores-Wilson, K., additional, Biggs, M.M., additional, Podawiltz, A., additional, Crisman, M.L., additional, Shan, S., additional, Mason, M., additional, and Rush, A.J., additional
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- 2000
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8. PMH12 Texas Medication Algorithm Project: Feasibility Study of Implementing Medication Algorithms in the Public Mental Health Sector
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Crismon, ML, primary, Rush, AJ, additional, Toprac, MG, additional, Shon, S, additional, Biggs, MM, additional, Shores-Wilson, K, additional, and Mason, M, additional
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- 1998
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9. Acceptability of second-step treatments to depressed outpatients: a STAR*D report.
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Wisniewski SR, Fava M, Trivedi MH, Thase ME, Warden D, Niederehe G, Friedman ES, Biggs MM, Sackeim HA, Shores-Wilson K, McGrath PJ, Lavori PW, Miyahara S, and Rush AJ
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OBJECTIVE: Treatment of major depressive disorder typically entails implementing treatments in a stepwise fashion until a satisfactory outcome is achieved. This study sought to identify factors that affect patients' willingness to accept different second-step treatment approaches. METHOD: Participants in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial who had unsatisfactory outcomes after initial treatment with citalopram were eligible for a randomized second-step treatment trial. An equipoise-stratified design allowed participants to exclude or include specific treatment strategies. Analyses were conducted to identify factors associated with the acceptability of the following second-step treatments: cognitive therapy versus no cognitive therapy, any switch strategy versus any augmentation strategy (including cognitive therapy), and a medication switch strategy only versus a medication augmentation strategy only. RESULTS: Of the 1,439 participants who entered second-step treatment, 1% accepted all treatment strategies, 3% accepted only cognitive therapy, and 26% accepted cognitive therapy (thus, 71% did not accept cognitive therapy). Those with higher educational levels or a family history of a mood disorder were more likely to accept cognitive therapy. Participants in primary care settings and those who experienced a greater side effect burden or a lower reduction in symptom severity with citalopram were more likely to accept a switch strategy as compared with an augmentation strategy. Those with concurrent drug abuse and recurrent major depressive disorder were less likely to accept a switch strategy. CONCLUSIONS: Few participants accepted all treatments. Acceptance of cognitive therapy was primarily associated with sociodemographic characteristics, while acceptance of a treatment switch was associated with the results of the initial treatment. [ABSTRACT FROM AUTHOR]
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- 2007
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10. A comparison of lithium and T3 augmentation following two failed medication treatments for depression: a STAR*D report.
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Nierenberg AA, Fava M, Trivedi MH, Wisniewski SR, Thase ME, McGrath PJ, Alpert JE, Warden D, Luther JF, Niederehe G, Lebowitz B, Shores-Wilson K, Rush AJ, and STAR*D Study Team
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OBJECTIVE: More than 40% of patients with major depressive disorder do not achieve remission even after two optimally delivered trials of antidepressant medications. This study compared the effectiveness of lithium versus triiodothyronine (T(3)) augmentation as a third-step treatment for patients with major depressive disorder. METHOD: A total of 142 adult outpatients with nonpsychotic major depressive disorder who had not achieved remission or who were intolerant to an initial prospective treatment with citalopram and a second switch or augmentation trial were randomly assigned to augmentation with lithium (up to 900 mg/day; N=69) or with T(3) (up to 50 microg/day; N=73) for up to 14 weeks. The primary outcome measure was whether participants achieved remission, which was defined as a score =7 on the 17-item Hamilton Depression Rating Scale. RESULTS: After a mean of 9.6 weeks (SD=5.2) of treatment, remission rates were 15.9% with lithium augmentation and 24.7% with T(3) augmentation, although the difference between treatments was not statistically significant. Lithium was more frequently associated with side effects (p=0.045), and more participants in the lithium group left treatment because of side effects (23.2% versus 9.6%; p=0.027). CONCLUSIONS: Remission rates with lithium and T(3) augmentation for participants who experienced unsatisfactory results with two prior medication treatments were modest and did not differ significantly. The lower side effect burden and ease of use of T(3) augmentation suggest that it has slight advantages over lithium augmentation for depressed patients who have experienced several failed medication trials. [ABSTRACT FROM AUTHOR]
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- 2006
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11. Tranylcypromine versus venlafaxine plus mirtazapine following three failed antidepressant medication trials for depression: a STAR*D report.
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McGrath PJ, Stewart JW, Fava M, Trivedi MH, Wisniewski SR, Nierenberg AA, Thase ME, Davis L, Biggs MM, Shores-Wilson K, Luther JF, Niederehe G, Warden D, Rush AJ, and STAR*D Study Team
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OBJECTIVE: The purpose of this study was to compare the effectiveness and tolerability of tranylcypromine and combination treatment with extended-release venlafaxine and mirtazapine in patients with treatment-resistant major depression whose current depressive episode had not responded adequately to treatment in three prior prospective medication trials. METHOD: Adult outpatients with nonpsychotic major depressive disorder who had not achieved remission or had withdrawn from treatment because of intolerance in three previous prospective medication trials were randomly assigned to receive open-label treatment with either tranylcypromine (N=58) or extended-release venlafaxine plus mirtazapine (N=51). The primary outcome measure was whether patients achieved remission, which was defined as a score =7 at exit on the 17-item Hamilton Depression Rating Scale (HAM-D). The HAM-D was administered by telephone by raters to whom treatment was masked. RESULTS: Remission rates were not significantly different between the two treatment groups (6.9% for the tranylcypromine group and 13.7% for the venlafaxine plus mirtazapine group). The mean daily dose at exit for tranylcypromine was 36.9 mg (SD=18.5); for venlafaxine, 210.3 mg (SD=95.2); and for mirtazapine, 35.7 mg (SD=17.6). Tranylcypromine was associated with significantly less symptom reduction and greater attrition due to intolerance. CONCLUSIONS: Remission rates were modest for both the tranylcypromine group and the extended-release venlafaxine plus mirtazapine group, and the rates were not statistically different between groups. The lower side effect burden, lack of dietary restrictions, and ease of use of venlafaxine and mirtazapine suggest that this combination may be preferred over tranylcypromine for patients with highly treatment-resistant depression who have not benefited adequately from several prior treatments. [ABSTRACT FROM AUTHOR]
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- 2006
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12. Comparison of self-report and clinician ratings on two inventories of depressive symptomatology.
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Rush AJ, Carmody TJ, Ibrahim HM, Trivedi MH, Biggs MM, Shores-Wilson K, Crismon ML, Toprac MG, Kashner TM, Rush, A John, Carmody, Thomas J, Ibrahim, Hisham M, Trivedi, Madhukar H, Biggs, Melanie M, Shores-Wilson, Kathy, Crismon, M Lynn, Toprac, Marcia G, and Kashner, T Michael
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Objective: This study evaluated the concordance between the self-report and the clinician-rated versions of the Inventory of Depressive Symptomatology (IDS-30) and between the two versions of the briefer 16-item Quick Inventory of Depressive Symptomatology (QIDS-16).Methods: Data were gathered for 544 adult outpatients with psychotic (N = 106) or nonpsychotic (N = 438) major depressive disorder at 14 public sector mental health clinics in the Texas Medication Algorithm Project. Data for the QIDS-16 were extracted from the IDS-30. Baseline scores and scores from the final study visit at or before month 12 were analyzed. The clinician-rated and the self-report versions of each scale were compared in their identification of response to treatment and remission.Results: The average baseline IDS-SR-30 total score was 2.2 points higher (indicating greater severity) than the IDS-C-30 score; the average QIDS-SR-16 total score was only .3 points higher than the QIDS-C-16 score. The IDS-SR-30 and the IDS-C-30, as well as the QIDS-C-16 and QIDS-SR-16, agreed substantially in classifying response and remission for patients, regardless of whether the patients had psychotic features. None of a large number of clinical and demographic features accounted for differences between the QIDS-SR-16 and QIDS-C-16 total scores.Conclusions: Either the IDS-30 or the QIDS-16 self-report adequately assesses depressive symptom severity among public-sector outpatients with major depressive disorder. The briefer QIDS-16 may be preferred to save time and cost. [ABSTRACT FROM AUTHOR]- Published
- 2006
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13. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice.
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Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, Norquist G, Howland RH, Lebowitz B, McGrath PJ, Shores-Wilson K, Biggs MM, Balasubramani GK, Fava M, STAR*D (Sequenced Treatment Alternatives to Relieve Depression) Study Team, Trivedi, Madhukar H, Rush, A John, Wisniewski, Stephen R, Nierenberg, Andrew A, and Warden, Diane
- Abstract
Objective: Selective serotonin reuptake inhibitors (SSRIs) are widely used to treat depression, but the rates, timing, and baseline predictors of remission in "real world" patients are not established. The authors' primary objectives in this study were to evaluate the effectiveness of citalopram, an SSRI, using measurement-based care in actual practice, and to identify predictors of symptom remission in outpatients with major depressive disorder.Method: This clinical study included outpatients with major depressive disorder who were treated in 23 psychiatric and 18 primary care "real world" settings. The patients received flexible doses of citalopram prescribed by clinicians for up to 14 weeks. The clinicians were assisted by a clinical research coordinator in the application of measurement-based care, which included the routine measurement of symptoms and side effects at each treatment visit and the use of a treatment manual that described when and how to modify medication doses based on these measures. Remission was defined as an exit score ofor=50% in baseline QIDS-SR score. Results: Nearly 80% of the 2,876 outpatients in the analyzed sample had chronic or recurrent major depression; most also had a number of comorbid general medical and psychiatric conditions. The mean exit citalopram dose was 41.8 mg/day. Remission rates were 28% (HAM-D) and 33% (QIDS-SR). The response rate was 47% (QIDS-SR). Patients in primary and psychiatric care settings did not differ in remission or response rates. A substantial portion of participants who achieved either response or remission at study exit did so at or after 8 weeks of treatment. Participants who were Caucasian, female, employed, or had higher levels of education or income had higher HAM-D remission rates; longer index episodes, more concurrent psychiatric disorders (especially anxiety disorders or drug abuse), more general medical disorders, and lower baseline function and quality of life were associated with lower HAM-D remission rates.Conclusions: The response and remission rates in this highly generalizable sample with substantial axis I and axis III comorbidity closely resemble those seen in 8-week efficacy trials. The systematic use of easily implemented measurement-based care procedures may have assisted in achieving these results. [ABSTRACT FROM AUTHOR]- Published
- 2006
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14. Clinical correlates and symptom patterns of anxious depression among patients with major depressive disorder in STAR*D.
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Fava M, Alpert JE, Carmin CN, Wisniewski SR, Trivedi MH, Biggs MM, Shores-Wilson K, Morgan D, Schwartz T, Balasubramani GK, and Rush AJ
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BACKGROUND: Anxious depression, defined as Major Depressive Disorder (MDD) with high levels of anxiety symptoms, may represent a relatively common depressive subtype, with distinctive features. OBJECTIVE: The objective of this study was to determine the prevalence of anxious depression and to define its clinical correlates and symptom patterns. METHOD: Baseline clinical and sociodemographic data were collected on 1450 subjects participating in the STAR*D study. A baseline Hamilton Rating Scale for Depression (HAM-D) Anxiety/ Somatization factor score of > or =7 was considered indicative of anxious depression. The types and degree of concurrent psychiatric symptoms were measured using the Psychiatric Diagnostic Screening Questionnaire (PDSQ), by recording the number of items endorsed by study participants for each diagnostic category. MDD symptoms were assessed by clinical telephone interview with the 30-item Inventory of Depressive Symptomatology (IDS-C30). RESULTS: The prevalence of anxious depression in this population was 46%. Patients with anxious MDD were significantly more likely to be older, unemployed, less educated, more severely depressed, and to have suicidal ideation before and after adjustment for severity of depression. As far as concurrent psychiatric symptoms are concerned, patients with anxious depression were significantly more likely to endorse symptoms related to generalized anxiety, obsessive compulsive, panic, post-traumatic stress, agoraphobia, hypochondriasis, and somatoform disorders before and after adjustment for severity of depression. Anxious-depression individuals were also significantly less likely to endorse IDS-C30 items concerning atypical features, and were significantly more likely to endorse items concerning melancholic/endogenous depression features. CONCLUSION: This study supports specific clinical and sociodemographic correlates of MDD associated with high levels of anxiety (anxious depression). [ABSTRACT FROM AUTHOR]
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- 2004
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15. A comparison of alternative assessments of depressive symptom severity: a pilot study
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Biggs, M. M., Shores-Wilson, K., Rush, A. J., Carmody, T. J., Trivedi, M. H., Crismon, M. L., Toprac, M. G., and Mason, M.
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- 2000
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16. Clinical and sociodemographic characteristics associated with suicidal ideation in depressed outpatients
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Trivedi, M. H., Morris, D. W., Stephen Wisniewski, Nierenberg, A. A., Gaynes, B. N., Kurian, B. T., Warden, D., Stegman, D., Shores-Wilson, K., and Rush, A. J.
17. Implementing guidelines and systems of care: Experiences with the Texas Medication Algorithm Project (TMAP)
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Rush, A. J., Crismon, M. L., Toprac, M. G., Shon, S. P., Rago, W. V., Miller, A. L., Suppes, T., Madhukar Trivedi, Biggs, M. M., Shores-Wilson, K., Kashner, T. M., and Altshuler, K. Z.
18. Voice response system to measure healthcare costs: A STAR*D Report
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Kashner, T. M., Trivedi, M. H., Wicker, A., Fava, M., Greist, J. H., Mundt, J. C., Shores-Wilson, K., Augustus Rush, and Wisniewski, S. R.
19. Clinical and demographic features of atypical depression in outpatients with major depressive disorder: Preliminary findings from STAR*D
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Novick, J. S., Stewart, J. W., Stephen Wisniewski, Cook, I. A., Manev, R., Nierenberg, A. A., Rosenbaum, J. F., Shores-Wilson, K., Balasubramani, G. K., Biggs, M. M., Zisook, S., and Rush, A. J.
20. What clinical and symptom features and comorbid disorders characterize outpatients with anxious major depressive disorder: A replication and extension
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Fava, M., Augustus Rush, Alpert, J. E., Carmin, C. N., Balasubramani, G. K., Wisniewski, S. R., Trivedi, M. H., Biggs, M. M., and Shores-Wilson, K.
21. Dr. McGrath and colleagues reply [2]
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Mcgrath, P. J., Stewart, J. W., Fava, M., Trivedi, M. H., Wisniewski, S. R., Nierenberg, A. A., Thase, M. E., Davis, L., Biggs, M. M., Shores-Wilson, K., Luther, J. F., Warden, D., and Augustus Rush
22. Treatment with low doses of tranylcypromine resulted in a disappointing remission rate.
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Nolen WA, van den Broek WW, Birkenhager TK, McGrath PJ, Stewart JW, Fava M, Trivedi MH, Wisniewski SR, Nierenberg AA, Thase ME, Davis L, Biggs MM, Shores-Wilson K, Luther JF, Warden D, and Rush AJ
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- 2007
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23. PMH12Texas Medication Algorithm Project: Feasibility Study of Implementing Medication Algorithms in the Public Mental Health Sector
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Crismon, ML, Rush, AJ, Toprac, MG, Shon, S, Biggs, MM, Shores-Wilson, K, and Mason, M
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OBJECTIVE: The aim of this study was to determine the feasibility and suitability of implementing consensually derived, evidence based, medication algorithms in the care of patients treated in the public mental health sector. METHODS: Each of 40 physicians at 16 sites treated 5–15 patients for up to 4 months with one of the algorithms (schizophrenia [SCZ], bipolar disorder [BPD], or major depressive disorder [MDD]. Process measures included visit frequency, staff time, algorithm stages used, time on treatment stage, and medications used. Outcome measures included the Brief Psychiatric Rating Scale (BPRS), Inventory of Depressive Symptoms (IDS), Clinical Global Impression (CGI), and the Multnomah Community Abilities Scale (MCAS). RESULTS: 222 patients entered the study. Survival rate at 90 days was 75%. Physician time was approximately 40 minutes at the initial visit and 30 minutes at follow-up visits; visits were approximately 3 weeks apart. 52% of patients with SCZ and 55% of patients with BPD had >30% decrease in BPRS score. 38% of patients with MDD had >50% decrease in IDS score. All patient groups except outpatient SCZ had significant improvement on the MCAS. Physician satisfaction was high with nearly 80% of the physicians stating that they would continue using the algorithms. CONCLUSIONS: Medication algorithms were implemented in the population and in general were associated with good improvement in patient symptoms and function. Major obstacles to widespread implementation are adequate staffing, staff support, and availability of certain medications. Clinical and economic impact of the algorithms are currently being evaluated in a comparative study.
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- 1998
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24. Bupropion and Naltrexone in Methamphetamine Use Disorder.
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Trivedi, M. H., Walker, R., Ling, W., Cruz, A. dela, Sharma, G., Carmody, T., Ghitza, U. E., Wahle, A., Kim, M., Shores-Wilson, K., Sparenborg, S., Coffin, P., Schmitz, J., Wiest, K., Bart, G., Sonne, S. C., Wakhlu, S., Rush, A. J., Nunes, E. V., and Shoptaw, S.
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BUPROPION , *NALTREXONE , *METHAMPHETAMINE , *DRUG efficacy , *DRUGS of abuse , *RESEARCH , *SUBSTANCE abuse , *NARCOTIC antagonists , *COMBINATION drug therapy , *INJECTIONS , *ORAL drug administration , *RESEARCH methodology , *EVALUATION research , *COMPARATIVE studies , *RANDOMIZED controlled trials , *CONTROLLED release preparations , *DRUGS , *BLIND experiment , *RESEARCH funding , *PATIENT compliance - Abstract
Background: The use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied.Methods: We conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone-bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone-bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses.Results: A total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone-bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone-bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone-bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone-bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone-bupropion during the trial.Conclusions: Among adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo. (Funded by the National Institute on Drug Abuse and others; ADAPT-2 ClinicalTrials.gov number, NCT03078075.). [ABSTRACT FROM AUTHOR]- Published
- 2021
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25. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression.
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Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M, and STAR*D STudy Team
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- 2006
26. Medication augmentation after the failure of SSRIs for depression.
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Trivedi MH, Fava M, Wisniewski SR, Thrase ME, Quitkin F, Warden D, Ritz L, Nierenberg AA, Lebowitz BD, Biggs MM, Luther JF, Shores-Wilson K, Rush AJ, and STAR*D Study Team
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- 2006
27. Moderation of buprenorphine therapy for cocaine dependence efficacy by variation of the Prodynorphin gene.
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Nielsen DA, Walker R, Graham DP, Nielsen EM, Hamon SC, Hillhouse M, Shmueli-Blumberg D, Lawson WB, Shores-Wilson K, Settles-Reaves BD, Rotrosen J, Trivedi MH, Saxon AJ, Ling W, and Kosten TR
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- Buprenorphine, Naloxone Drug Combination therapeutic use, Delayed-Action Preparations therapeutic use, Enkephalins, Humans, Injections, Intramuscular, Naltrexone therapeutic use, Narcotic Antagonists therapeutic use, Protein Precursors, Buprenorphine therapeutic use, Cocaine therapeutic use, Cocaine-Related Disorders drug therapy, Cocaine-Related Disorders genetics, Opioid-Related Disorders
- Abstract
Purpose: The aim of this secondary analysis was to identify prodynorphin (PDYN) genetic markers moderating the therapeutic response to treatment of cocaine dependence with buprenorphine/naloxone (Suboxone®; BUP)., Methods: Cocaine-dependent participants (N = 302) were randomly assigned to a platform of injectable, extended-release naltrexone (XR-NTX) and one of three daily medication arms: 4 mg BUP (BUP4), 16 mg BUP (BUP16), or placebo (PLB) for 8 weeks (Parent Trial Registration: Protocol ID: NIDA-CTN-0048, Clinical Trials.gov ID: NCT01402492). DNA was obtained from 277 participants. Treatment response was determined from weeks 3 to 7 over each 1-week period by the number of cocaine-positive urines per total possible urines., Results: In the cross-ancestry group, the PLB group had more cocaine-positive urines than the BUP16 group (P = 0.0021). The interactions of genetic variant × treatment were observed in the rs1022563 A-allele carrier group where the BUP16 group (N = 35) had fewer cocaine-positive urines (P = 0.0006) than did the PLB group (N = 26) and in the rs1997794 A-allele carrier group where the BUP16 group (N = 49) had fewer cocaine-positive urines (P = 0.0003) than did the PLB group (N = 58). No difference was observed in the rs1022563 GG or rs1997794 GG genotype groups between the BUP16 and PLB groups. In the African American-ancestry subgroup, only the rs1022563 A-allele carrier group was associated with treatment response., Conclusion: These results suggest that PDYN variants may identify patients who are best suited to treatment with XR-NTX plus buprenorphine for cocaine use disorder pharmacotherapy., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2022
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28. Identifying and responding to trial implementation challenges during multisite clinical trials.
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Greer TL, Walker R, Rethorst CD, Northrup TF, Warden D, Horigian VE, Silverstein M, Shores-Wilson K, Stotts AL, and Trivedi MH
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- Humans, Longitudinal Studies, National Institute on Drug Abuse (U.S.), Research Design, United States, Central Nervous System Stimulants, Substance-Related Disorders therapy
- Abstract
Introduction: The National Drug Abuse Treatment Clinical Trials Network (CTN) was initiated by the National Institute on Drug Abuse (NIDA) in 2000 with the aim of improving substance use treatment and reducing the time between the discovery of effective treatments and their implementation into clinical practice. While initial trials were conducted almost exclusively in specialty addiction treatment settings, the CTN began evolving strategically in 2010 to conduct research in general medical settings, including healthcare systems, primary care settings, emergency departments, and pharmacies, to broaden impact. The advantages of a research network like the CTN is not only the collective content expertise that investigators contribute to the network, but the collective experience gained by conducting studies in the network and then applying those lessons to future studies., Objective: To summarize trial implementation challenges encountered, and the process by which solutions were identified and implemented, within one of the last early-phase CTN Stage II behavioral intervention studies conducted in a specialty addiction treatment setting., Method and Results: We describe the implementation of the CTN-0037 STimulant Reduction Intervention using Dosed Exercise (STRIDE) trial. Issues encountered during study implementation are categorized into four major areas, described in terms useful to future study teams: 1) study team infrastructure challenges, 2) participant- and site- level challenges, 3) intervention-related challenges, and 4) longitudinal study design challenges. Potential consequences of identified problems and the solutions developed to manage these problems are discussed within the context of these four areas. We propose how to extend these implementation lessons and apply them in other healthcare settings to expand the CTN., Conclusions: Effective study management allows for flexible, collaborative solutions to expected and unexpected obstacles to study success. Implementation strategies derived from the first 15 to 20 years of CTN studies are a result of working with providers and participants, and the ongoing collaboration among CTN investigators and network staff. Timely identification and response to problems during study implementation are critical to the success of a trial, regardless of its design. We believe a collaborative approach to identifying and responding to study implementation challenges will increase the likelihood of successful adoption of relevant, efficacious interventions. As the CTN continues to expand, the wealth of successful trial implementation strategies developed during the first 20 years of the CTN need to be applied and adapted to studies in broader network settings, and considered in conjunction with more formalized implementation science processes that are currently available., Competing Interests: Declaration of competing interest Drs. Shores-Wilson, Walker, Rethorst, Northrup, Silverstein, Horigian, and Stotts have no conflicting interests to declare. Dr. Greer has received research funding from NARSAD and contracted research support from Janssen Research & Development, LLC. She has received consultant fees from H. Lundbeck A/S and Takeda Pharmaceuticals International, Inc. Dr. Warden has owned stock in Pfizer, Inc. and Bristol-Myers Squibb Company within the last five years and has received funding from NARSAD. Dr. Trivedi has served as an adviser or consultant for Abbott Laboratories, Abdi Ibrahim, Akzo (Organon Pharmaceuticals), Alkermes, AstraZeneca, Axon Advisors, Bristol-Myers Squibb, Cephalon, Cerecor, CME Institute of Physicians, Concert Pharmaceuticals, Eli Lilly, Evotec, Fabre Kramer Pharmaceuticals, Forest Pharmaceuticals, GlaxoSmithKline, Janssen Global Services, Janssen Pharmaceutica Products, Johnson & Johnson PRD, Libby, Lundbeck, Meade Johnson, MedAvante, Medtronic, Merck, Mitsubishi Tanabe Pharma Development America, Naurex, Neuronetics, Otsuka Pharmaceuticals, Pamlab, Parke-Davis Pharmaceuticals, Pfizer, PgxHealth, Phoenix Marketing Solutions, Rexahn Pharmaceuticals, Ridge Diagnostics, Roche Products, Sepracor, Shire Development, Sierra, SK Life and Science, Sunovion, Takeda, Tal Medical/Puretech Venture, Targacept, Transcept, VantagePoint, Vivus, and Wyeth-Ayerst Laboratories; he has received grants or research support from the Agency for Healthcare Research and Quality, Cyberonics, NARSAD, NIDA, and NIMH., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2020
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29. Age differences in outcomes among patients in the "Stimulant Abuser Groups to Engage in 12-Step" (STAGE-12) intervention.
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Garrett SB, Doyle SR, Peavy KM, Wells EA, Owens MD, Shores-Wilson K, DiCenzo J, and Donovan DM
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- Adult, Age Factors, Female, Humans, Male, Time Factors, Young Adult, Central Nervous System Stimulants adverse effects, Patient Compliance, Self-Help Groups, Substance-Related Disorders rehabilitation
- Abstract
Emerging adults (roughly 18-29years) with substance use disorders can benefit from participation in twelve-step mutual-help organizations (TSMHO), however their attendance and participation in such groups is relatively low. Twelve-step facilitation therapies, such as the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12), may increase attendance and involvement, and lead to decreased substance use., Aims: Analyses examined whether age moderated the STAGE-12 effects on substance use and TSMHO meeting attendance and participation., Design: We utilized data from a multisite randomized controlled trial, with assessments at baseline, mid-treatment (week 4), end-of-treatment (week 8), and 3- and 6- months post-randomization., Participants: Participants were adults with DSM-IV diagnosed stimulant abuse or dependence (N=450) enrolling in 10 intensive outpatient substance use treatment programs across the U.S., Analysis: A zero-inflated negative binomial random-effects regression model was utilized to examine age-by-treatment interactions on substance use and meeting attendance and involvement., Findings: Younger age was associated with larger treatment effects for stimulant use. Specifically, younger age was associated with greater odds of remaining abstinent from stimulants in STAGE-12 versus Treatment-as-Usual; however, among those who were not abstinent during treatment, younger age was related to greater rates of stimulant use at follow-up for those in STAGE-12 compared to TAU. There was no main effect of age on stimulant use. Younger age was also related to somewhat greater active involvement in different types of TSMHO activities among those in STAGE-12 versus TAU. There were no age-by-treatment interactions for other types of substance use or for treatment attendance, however, in contrast to stimulant use; younger age was associated with lower odds of abstinence from non-stimulant drugs at follow-up, regardless of treatment condition. These results suggest that STAGE-12 can be beneficial for some emerging adults with stimulant use disorder, and ongoing assessment of continued use is of particular importance., (Copyright © 2017 Elsevier Inc. All rights reserved.)
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- 2018
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30. Randomized Controlled Trial Comparing Exercise to Health Education for Stimulant Use Disorder: Results From the CTN-0037 STimulant Reduction Intervention Using Dosed Exercise (STRIDE) Study.
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Trivedi MH, Greer TL, Rethorst CD, Carmody T, Grannemann BD, Walker R, Warden D, Shores-Wilson K, Stoutenberg M, Oden N, Silverstein M, Hodgkins C, Love L, Seamans C, Stotts A, Causey T, Szucs-Reed RP, Rinaldi P, Myrick H, Straus M, Liu D, Lindblad R, Church T, Blair SN, and Nunes EV
- Subjects
- Adult, Diagnostic and Statistical Manual of Mental Disorders, Female, Humans, Male, Middle Aged, Patient Compliance psychology, Treatment Outcome, Central Nervous System Stimulants pharmacology, Exercise physiology, Exercise Therapy methods, Exercise Therapy psychology, Health Education methods, Substance-Related Disorders diagnosis, Substance-Related Disorders etiology, Substance-Related Disorders psychology, Substance-Related Disorders therapy
- Abstract
Objective: To evaluate exercise as a treatment for stimulant use disorders., Methods: The STimulant Reduction Intervention using Dosed Exercise (STRIDE) study was a randomized clinical trial conducted in 9 residential addiction treatment programs across the United States from July 2010 to February 2013. Of 497 adults referred to the study, 302 met all eligibility criteria, including DSM-IV criteria for stimulant abuse and/or dependence, and were randomized to either a dosed exercise intervention (Exercise) or a health education intervention (Health Education) control, both augmenting treatment as usual and conducted thrice weekly for 12 weeks. The primary outcome of percent stimulant abstinent days during study weeks 4 to 12 was estimated using a novel algorithm adjustment incorporating self-reported Timeline Followback (TLFB) stimulant use and urine drug screen (UDS) data., Results: Mean percent of abstinent days based on TLFB was 90.8% (SD = 16.4%) for Exercise and 91.6% (SD = 14.7%) for Health Education participants. Percent of abstinent days using the eliminate contradiction (ELCON) algorithm was 75.6% (SD = 27.4%) for Exercise and 77.3% (SD = 25.1%) for Health Education. The primary intent-to-treat analysis, using a mixed model controlling for site and the ELCON algorithm, produced no treatment effect (P = .60). In post hoc analyses controlling for treatment adherence and baseline stimulant use, Exercise participants had a 4.8% higher abstinence rate (78.7%) compared to Health Education participants (73.9%) (P = .03, number needed to treat = 7.2)., Conclusions: The primary analysis indicated no significant difference between exercise and health education. Adjustment for intervention adherence showed modestly but significantly higher percent of abstinent days in the exercise group, suggesting that exercise may improve outcomes for stimulant users who have better adherence to an exercise dose., Trial Registration: ClinicalTrials.gov identifier: NCT01141608., (© Copyright 2017 Physicians Postgraduate Press, Inc.)
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- 2017
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31. Gender-based Outcomes and Acceptability of a Computer-assisted Psychosocial Intervention for Substance Use Disorders.
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Campbell AN, Nunes EV, Pavlicova M, Hatch-Maillette M, Hu MC, Bailey GL, Sugarman DE, Miele GM, Rieckmann T, Shores-Wilson K, Turrigiano E, and Greenfield SF
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- Adult, Female, Humans, Male, Middle Aged, Treatment Outcome, Gender Identity, Patient Acceptance of Health Care, Substance-Related Disorders therapy, Therapy, Computer-Assisted methods
- Abstract
Background: Digital technologies show promise for increasing treatment accessibility and improving quality of care, but little is known about gender differences. This secondary analysis uses data from a multi-site effectiveness trial of a computer-assisted behavioral intervention, conducted within NIDA's National Drug Abuse Clinical Trials Network, to explore gender differences in intervention acceptability and treatment outcomes., Methods: Men (n=314) and women (n=192) were randomly assigned to 12-weeks of treatment-as-usual (TAU) or modified TAU+Therapeutic Education System (TES), whereby TES substituted for 2hours of TAU per week. TES is composed of 62 Web-delivered, multimedia modules, covering skills for achieving and maintaining abstinence plus prize-based incentives contingent on abstinence and treatment adherence. Outcomes were: (1) abstinence from drugs and heavy drinking in the last 4weeks of treatment, (2) retention, (3) social functioning, and (4) drug and alcohol craving. Acceptability was the mean score across five indicators (i.e., interesting, useful, novel, easy to understand, and satisfaction)., Results: Gender did not moderate the effect of treatment on any outcome. Women reported higher acceptability scores at week 4 (p=.02), but no gender differences were detected at weeks 8 or 12. Acceptability was positively associated with abstinence, but only among women (p=.01)., Conclusions: Findings suggest that men and women derive similar benefits from participating in a computer-assisted intervention, a promising outcome as technology-based treatments expand. Acceptability was associated with abstinence outcomes among women. Future research should explore characteristics of women who report less satisfaction with this modality of treatment and ways to improve overall acceptability., (Copyright © 2015 Elsevier Inc. All rights reserved.)
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- 2015
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32. Clinical and sociodemographic characteristics associated with suicidal ideation in depressed outpatients.
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Trivedi MH, Morris DW, Wisniewski SR, Nierenberg AA, Gaynes BN, Kurian BT, Warden D, Stegman D, Shores-Wilson K, and Rush AJ
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- Adult, Affective Symptoms epidemiology, Affective Symptoms etiology, Affective Symptoms therapy, Aged, Comorbidity, Demography statistics & numerical data, Drug Substitution methods, Drug Substitution statistics & numerical data, Drug Therapy, Combination methods, Drug Therapy, Combination statistics & numerical data, Female, Humans, Male, Middle Aged, Outcome and Process Assessment, Health Care, Outpatients psychology, Outpatients statistics & numerical data, Psychiatric Status Rating Scales, Remission Induction, Risk Factors, Selective Serotonin Reuptake Inhibitors therapeutic use, Socioeconomic Factors, Treatment Outcome, United States epidemiology, Antidepressive Agents classification, Antidepressive Agents therapeutic use, Cognitive Behavioral Therapy methods, Cognitive Behavioral Therapy statistics & numerical data, Depressive Disorder, Major complications, Depressive Disorder, Major diagnosis, Depressive Disorder, Major epidemiology, Depressive Disorder, Major therapy, Suicidal Ideation, Suicide psychology, Suicide statistics & numerical data, Suicide Prevention
- Abstract
Objective: To identify clinical and sociodemographic characteristics associated with suicidal ideation (SI) among patients seeking care for depression in routine primary and psychiatric care settings., Methods: We examined data from 4041 treatment-seeking outpatients with major depressive disorder (MDD) to compare baseline sociodemographic and clinical characteristics of those with and without SI, and the presence or absence of baseline depressive symptoms and psychiatric comorbidities in those with SI., Results: SI was significantly (P < 0.01) associated with numerous sociodemographic characteristics (that is, lower level of education, Caucasian or African American, male, unemployed, and treated in psychiatric care) and clinical features (that is, previous suicide attempt, younger age of MDD onset, greater baseline depressive symptom severity, greater number of depressive symptoms, and presence of agoraphobia and [or] generalized anxiety disorder). Elevated levels of SI at baseline were associated with decreased remission rates., Conclusions: Consistent with past findings, increased rates of SI were associated with greater depressive symptom severity as well as other features suggestive of severity of illness. Our results confirm previous findings of associations between SI and panic and (or) phobic symptoms and anxiety, but did not confirm previous findings of an association between SI and alcohol or drug use and (or) dependence. While selective serotonin reuptake inhibitor monotherapy appeared significantly helpful in reducing SI during the course of treatment, the presence of SI at baseline was found to be a associated with decreased treatment response, with patients reporting SI at the start of treatment being less likely to achieve remission., Clinical Trial Registration Number: Sequenced Treatment Alternatives to Relieve Depression, NCT00021528.
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- 2013
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33. Release bias in accessing medical records in clinical trials: a STAR*D report.
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Kashner TM, Trivedi MH, Wicker A, Fava M, Shores-Wilson K, Wisniewski SR, and Rush AJ
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- Adult, Aged, Chi-Square Distribution, Depression epidemiology, Female, Humans, Interviews as Topic, Male, Middle Aged, Odds Ratio, Young Adult, Bias, Clinical Trials as Topic, Depression psychology, Depression therapy, Medical Records statistics & numerical data, Multicenter Studies as Topic
- Abstract
Clinical trials often require subjects to sign medical record releases to allow investigators to measure treatment fidelity, off-protocol care use, and care costs. Little is known, however, if limiting samples to those willing to sign releases impacts external validity. Data came from outpatients with non-psychotic major depressive disorder who enrolled in the multisite Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Differences between those who signed (n = 3116) and who did not sign (n = 925) releases were assessed using logistic regression and two-part, three-level log-transformed regression models, corrected for site clustering and repeated measures. Patients who released records tended to believe care was helpful, were younger, and married. However, release status had little material or consistent associations with patient health outcomes or use of care. With appropriate adjustments to data, requiring patient medical records may pose only minimal challenges to external validity in cost-outcome studies., ((c) 2009 John Wiley & Sons, Ltd.)
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- 2009
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34. What predicts attrition in second step medication treatments for depression?: a STAR*D Report.
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Warden D, Rush AJ, Wisniewski SR, Lesser IM, Kornstein SG, Balasubramani GK, Thase ME, Preskorn SH, Nierenberg AA, Young EA, Shores-Wilson K, and Trivedi MH
- Subjects
- Adolescent, Adult, Aged, Antidepressive Agents adverse effects, Antidepressive Agents, Second-Generation therapeutic use, Bupropion therapeutic use, Buspirone therapeutic use, Citalopram adverse effects, Citalopram therapeutic use, Data Interpretation, Statistical, Depressive Disorder, Major complications, Depressive Disorder, Major psychology, Drug Therapy, Combination, Female, Forecasting, Humans, Male, Middle Aged, Outpatients, Prospective Studies, Psychiatric Status Rating Scales, Quality of Life, Serotonin Receptor Agonists therapeutic use, Socioeconomic Factors, Young Adult, Antidepressive Agents therapeutic use, Depressive Disorder, Major drug therapy, Patient Dropouts statistics & numerical data
- Abstract
Attrition rates are high during treatment for major depressive disorder (MDD), and patients who drop out are less likely to reach remission. This report evaluates the incidence, timing, and predictors of attrition during second-step medication treatment. Outpatients in the multisite Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study receiving a medication augmentation (n=563) or medication switch (n=723) for non-psychotic MDD after an unsatisfactory outcome with citalopram were evaluated to determine attrition rates and pretreatment sociodemographic or clinical predictors of attrition. Twenty percent of participants receiving a medication augmentation and 27% receiving a medication switch dropped out before 12 wk in the second treatment step. Remission rates were lower for dropouts [7% vs. 43% (medication augmentation); 12% vs. 31% (medication switch)]. For medication augmentation, Black and other non-Caucasian races, Hispanic ethnicity, younger age, family history of drug abuse, concurrent drug abuse, sociodemographic disadvantage, less symptom improvement with initial citalopram treatment, and greater symptom severity when beginning augmentation were associated with attrition. For medication switch, Black and other non-Caucasian races, younger age, more melancholic features, and lower exit doses but more severe side-effects with citalopram treatment were associated with attrition. Minority status, younger age, and greater difficulty with the first treatment step are risk factors for attrition in the second treatment step. Focus on patients with attrition risk factors for medication augmentation or switch strategies may enhance retention and improve outcomes.
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- 2009
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35. Voice response system to measure healthcare costs: a STAR*D report.
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Kashner TM, Trivedi MH, Wicker A, Fava M, Greist JH, Mundt JC, Shores-Wilson K, Rush AJ, and Wisniewski SR
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- Adult, Aged, Depressive Disorder, Major therapy, Female, Humans, Interviews as Topic, Male, Middle Aged, Odds Ratio, Reproducibility of Results, Self-Assessment, Surveys and Questionnaires, Depressive Disorder, Major psychology, Self Disclosure, Telephone
- Abstract
Objective: To evaluate a telephone-operated, interactive voice response (IVR) system designed to collect use-of-care data from patients with major depression (UAC-IVR)., Study Design: Patient self-reports from repeated IVR surveys were compared with provider records for 3789 patients with major depression at 41 clinical sites participating in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial., Methods: UAC-IVR responses were examined for consistency and compared with provider records to compute reporting biases and intraclass correlation coefficients. Predictors of inconsistent responses and reporting biases were based on mixed logistic and regression models adjusted for need and predisposing and enabling covariates, and corrected for nesting and repeated measures., Results: Inconsistent responses were found for 10% of calls and 21% of patients. Underreporting biases (-20%) and moderate agreement (intraclass correlation of 68%) were found when UAC-IVR responses were compared with medical records. IVR reporting biases were less for patients after 3 calls or more (experience), for patients with severe baseline symptoms (motivation), and for patients who gave consistent IVR responses (reliability). Bias was unrelated to treatment outcomes or demographic factors., Conclusion: Clinical managers should use IVR systems to collect service histories only after patients are properly trained and responses monitored for consistency and reporting biases.
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- 2009
36. Identifying risk for attrition during treatment for depression.
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Warden D, Trivedi MH, Wisniewski SR, Lesser IM, Mitchell J, Balasubramani GK, Fava M, Shores-Wilson K, Stegman D, and Rush AJ
- Subjects
- Adolescent, Adult, Aged, Attitude, Depressive Disorder, Major psychology, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Risk Factors, Selective Serotonin Reuptake Inhibitors adverse effects, Young Adult, Depressive Disorder, Major drug therapy, Patient Compliance psychology, Selective Serotonin Reuptake Inhibitors therapeutic use
- Abstract
Background: Understanding patients' ambivalence about treatment persistence may be useful in tailoring retention interventions for individual patients with major depressive disorder., Methods: Participants (n = 265) with major depressive disorder were enrolled into an 8-week trial with a selective serotonin reuptake inhibitor. At baseline and week 2, the participants were asked about their intent to return for the next visit, complete the study and continue in the study should they experience side effects or no improvement. Dropouts were defined as participants who discontinued attending clinic visits before completing the trial., Results: Participants who at baseline reported an uncertain/negative intent to continue if they experienced side effects or no improvement dropped out at a significantly higher rate by weeks 6 and 8. Uncertain/negative intent at week 2 predicted attrition at all following visits. Dropouts without side effects were more likely to have reported an uncertain/negative intent to attend at both baseline and week 2, while dropouts who experienced side effects were more likely to have reported an uncertain/negative intent to attend only at baseline. Positive intent to continue was associated with greater symptom improvement in both dropouts and completers despite the possibility of lack of efficacy., Conclusions: Participants' pretreatment concerns about continuing antidepressant treatment in the presence of side effects signals challenges to the completion of a full 8-week acute phase treatment, even if the participant does not develop side effects. Individualized review of concerns and tailoring appropriate interventions may be necessary to reduce attrition., (Copyright 2009 S. Karger AG, Basel.)
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- 2009
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37. Income and attrition in the treatment of depression: a STAR*D report.
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Warden D, Rush AJ, Wisniewski SR, Lesser IM, Thase ME, Balasubramani GK, Shores-Wilson K, Nierenberg AA, and Trivedi MH
- Subjects
- Adolescent, Adult, Age Factors, Aged, Ambulatory Care, Cognition Disorders epidemiology, Depressive Disorder epidemiology, Depressive Disorder, Major epidemiology, Educational Status, Ethnicity statistics & numerical data, Female, Humans, Male, Middle Aged, Patient Dropouts statistics & numerical data, Prospective Studies, Recurrence, Remission Induction, Retention, Psychology, Severity of Illness Index, Socioeconomic Factors, Substance-Related Disorders epidemiology, Substance-Related Disorders genetics, Surveys and Questionnaires, Young Adult, Citalopram therapeutic use, Depressive Disorder, Major drug therapy, Depressive Disorder, Major psychology, Income, Selective Serotonin Reuptake Inhibitors therapeutic use
- Abstract
Background: Attrition, or dropping out of treatment, remains a major issue in the care of depressed outpatients. Whether different factors are associated with attrition for different socioeconomic groups is not known. This report assessed whether attrition rates and predictors of attrition differed among depressed outpatients with different income levels., Methods: Outpatients with nonpsychotic major depressive disorder treated for up to 14 weeks with citalopram in the first step of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study were divided by household incomes of <$20,000, $20,000-<$40,000, and >or=$40,000. Attrition rates and sociodemographic and clinical correlates of attrition were identified for each group., Results: Regardless of income level, remission rates were lower for participants who dropped out of treatment. Attrition rates increased as income decreased. For all income levels, younger age was independently associated with attrition. For the lowest income level, less education, better mental health functioning, being on public insurance, and having more concurrent Axis I conditions were associated with a greater likelihood of attrition. For the middle income group, less education, better mental health functioning, being Black or of another non-White race, and treatment in a psychiatric versus primary-care setting predicted greater attrition. For the highest income group, being Hispanic, having a family history of drug abuse, and melancholic features predicted attrition. Atypical symptom features (middle income group) and recurrent depression (highest income group) were associated with retention., Conclusions: Efforts to retain patients in antidepressant treatment should focus especially on less educated patients with lower household incomes and younger patients.
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- 2009
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38. Family history of mood disorder and characteristics of major depressive disorder: a STAR*D (sequenced treatment alternatives to relieve depression) study.
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Nierenberg AA, Trivedi MH, Fava M, Biggs MM, Shores-Wilson K, Wisniewski SR, Balasubramani GK, and Rush AJ
- Subjects
- Adolescent, Adult, Age of Onset, Aged, Cohort Studies, Demography, Diagnostic and Statistical Manual of Mental Disorders, Female, Humans, Male, Middle Aged, Outpatients, Severity of Illness Index, Sex Factors, Depressive Disorder, Major epidemiology, Depressive Disorder, Major physiopathology, Family Health, Mood Disorders diagnosis, Mood Disorders epidemiology, Mood Disorders genetics
- Abstract
Introduction: Clinicians routinely ask patients with major depressive disorder (MDD) about their family history. It is unknown, however, if patients who report a positive family history differ from those who do not. This study compared the demographic and clinical features of a large cohort of treatment-seeking outpatients with non-psychotic MDD who reported that they did or did not have at least one first-degree relative who had either MDD or bipolar disorder., Methods: Subjects were recruited for the STAR( *)D multicenter trial. Differences in demographic and clinical features for patients with and without a family history of mood disorders were assessed after correcting for age, sex, race, and ethnicity., Results: Patients with a family history of mood disorder (n=2265; 56.5%) were more frequently women and had an earlier age of onset of depression, as compared to those without such a history (n=1740; 43.5%). No meaningful differences were found in depressive symptoms, severity, recurrence, depressive subtype, or daily function., Conclusions: Women were twice as likely as men to report a positive family history of mood disorder, and a positive family history was associated with younger age of onset of MDD in the proband. Consistent with prior research, early age of onset appears to define a familial and, by extension, genetic subtype of major depressive disorder.
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- 2007
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39. What clinical and symptom features and comorbid disorders characterize outpatients with anxious major depressive disorder: a replication and extension.
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Fava M, Rush AJ, Alpert JE, Carmin CN, Balasubramani GK, Wisniewski SR, Trivedi MH, Biggs MM, and Shores-Wilson K
- Subjects
- Adolescent, Adult, Aged, Comorbidity, Female, Humans, Male, Middle Aged, Primary Health Care methods, Prospective Studies, Ambulatory Care, Anxiety Disorders epidemiology, Anxiety Disorders therapy, Depressive Disorder, Major epidemiology, Depressive Disorder, Major therapy
- Abstract
Objective: We previously found that 46% of the first 1450 outpatients with depression participating in the multicentre Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project qualified for the designation of anxious depression. This study was designed to replicate and extend our initial findings in a subsequent, larger cohort of outpatient STAR*D participants with nonpsychotic major depressive disorder (MDD)., Methods: Baseline clinical and sociodemographic data were collected on 2337 consecutive STAR*D participants. A baseline 17-item Hamilton Depression Rating Scale Anxiety-Somatization factor score of 7 or higher was designated as anxious depression. We identified concurrent Axis I disorders with the Psychiatric Diagnostic Screening Questionnaire (PDSQ), using a 90% specificity threshold. Depressive symptoms were assessed by clinical telephone interview with the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)., Results: The prevalence of anxious depression in this population was 45.1%. Patients with anxious MDD were significantly more likely to be in primary care settings and to be women, nonsingle, unemployed, Hispanic, less educated, and suffering from severe depression, both before and after adjustment for overall depression severity. Patients with anxious depression were significantly more likely to meet PDSQ thresholds for generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, agoraphobia, hypochondriasis, and somatoform disorder, both before and after adjusting for baseline depression severity. Individuals with anxious depression were also significantly less likely to endorse IDS-C30 items concerning atypical features and were significantly more likely to endorse items concerning melancholic-endogenous depression features, both before and after adjusting for baseline depression severity., Conclusions: This study clearly replicates our previous STAR*D findings and supports the notion that anxious depression may be a valid diagnostic subtype of MDD, with distinct psychiatric comorbidities and clinical and sociodemographic features.
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- 2006
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40. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report.
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Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, and Fava M
- Subjects
- Adult, Aged, Ambulatory Care, Antidepressive Agents, Second-Generation adverse effects, Citalopram adverse effects, Depressive Disorder, Major diagnosis, Depressive Disorder, Major psychology, Evaluation Studies as Topic, Female, Humans, Interviews as Topic, Male, Middle Aged, Outcome Assessment, Health Care statistics & numerical data, Prospective Studies, Psychometrics statistics & numerical data, Reproducibility of Results, Speech Recognition Software, Statistics as Topic, Antidepressive Agents, Second-Generation therapeutic use, Citalopram therapeutic use, Depressive Disorder, Major drug therapy, Personality Inventory statistics & numerical data
- Abstract
Background: Nine DSM-IV-TR criterion symptom domains are evaluated to diagnose major depressive disorder (MDD). The Quick Inventory of Depressive Symptomatology (QIDS) provides an efficient assessment of these domains and is available as a clinician rating (QIDS-C16), a self-report (QIDS-SR16), and in an automated, interactive voice response (IVR) (QIDS-IVR16) telephone system. This report compares the performance of these three versions of the QIDS and the 17-item Hamilton Rating Scale for Depression (HRSD17)., Methods: Data were acquired at baseline and exit from the first treatment step (citalopram) in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Outpatients with nonpsychotic MDD who completed all four ratings within +/-2 days were identified from the first 1500 STAR*D subjects. Both item response theory and classical test theory analyses were conducted., Results: The three methods for obtaining QIDS data produced consistent findings regarding relationships between the nine symptom domains and overall depression, demonstrating interchangeability among the three methods. The HRSD17, while generally satisfactory, rarely utilized the full range of item scores, and evidence suggested multidimensional measurement properties., Conclusions: In nonpsychotic MDD outpatients without overt cognitive impairment, clinician assessment of depression severity using either the QIDS-C16 or HRSD17 may be successfully replaced by either the self-report or IVR version of the QIDS.
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- 2006
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41. Enrolling research subjects from clinical practice: ethical and procedural issues in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial.
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Alpert JE, Biggs MM, Davis L, Shores-Wilson K, Harlan WR, Schneider GW, Ford AL, Farabaugh A, Stegman D, Ritz AL, Husain MM, Macleod L, Wisniewski SR, and Rush AJ
- Subjects
- Adolescent, Adult, Aged, Combined Modality Therapy, Depressive Disorder, Major drug therapy, Depressive Disorder, Major economics, Female, Humans, Male, Middle Aged, Antidepressive Agents therapeutic use, Cognitive Behavioral Therapy ethics, Cognitive Behavioral Therapy methods, Depressive Disorder, Major therapy, Ethics, Clinical
- Abstract
The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial is a multi-site effectiveness study funded by the National Institute of Mental Health (NIMH) with the aim of identifying successful, acceptable and cost-effective treatment strategies for outpatients with unremitted depression. With enrollment of 4,041 adults with major depressive disorder (MDD), it is the largest controlled psychiatric treatment study ever undertaken. In the course of developing procedures to ensure that ambitious enrollment goals were met, a number of ethical and practical issues became apparent that underscore the conflicts between effectiveness research and human subject protections. These are delineated as they relate to study design; eligibility criteria; incentives to subjects; investigators and clinical sites; the complementary roles of clinical research coordinators (CRCs) and study clinicians; and recruitment and consent procedures. The STAR*D trial exemplifies the interplay and tension between those strategies that integrate research and clinical aims and roles in the service of enhancing external validity, site participation, and recruitment and retention versus those strategies that differentiate research and clinical treatment in the service of research integrity and human subject protections. We hope that a discussion of these key challenges and dilemmas and how they have been addressed will help inform future discussions concerning design and conduct of ethical effectiveness trials designed to optimize care in real world clinical settings.
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- 2006
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42. Presenting characteristics of depressed outpatients as a function of recurrence: preliminary findings from the STAR*D clinical trial.
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Hollon SD, Shelton RC, Wisniewski S, Warden D, Biggs MM, Friedman ES, Husain M, Kupfer DJ, Nierenberg AA, Petersen TJ, Shores-Wilson K, and Rush AJ
- Subjects
- Adolescent, Adult, Age Factors, Aged, Antidepressive Agents therapeutic use, Chronic Disease, Cognitive Behavioral Therapy, Depressive Disorder, Major epidemiology, Depressive Disorder, Major genetics, Depressive Disorder, Major psychology, Genetic Predisposition to Disease genetics, Humans, Middle Aged, Outcome Assessment, Health Care, Personality Inventory statistics & numerical data, Phenotype, Prospective Studies, Psychometrics, Recurrence, Risk Assessment, Socioeconomic Factors, Ambulatory Care, Depressive Disorder, Major diagnosis
- Abstract
Objectives: Recurrent depression predicts risk for subsequent episodes, but it is unclear how it relates to demographic features, course of illness, and clinical presentation., Methods: We report on the baseline data for the first 1500 patients enrolled in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study (www.star-d.org). Patients were required to have a DSM-IV diagnosis of nonpsychotic major depression and to score > or = 14 on the 17-item Hamilton rating scale for depression. Status with respect to recurrent depression and other aspects of illness course and demographic features were ascertained at intake, along with measures of depression and concurrent general medical illness., Results: Patients with recurrent depression were older, had an earlier age of onset, and were more likely to have a positive family history of depression than first episode patients. However, recurrent patients were less likely to be chronic and reported shorter current episodes than first episode patients, something that was largely confined to females. Recurrent patients were more likely than first episode patients to report non-essential aspects of mood, cognition, and somatic symptoms, although largely as a consequence of greater overall depressive symptom severity., Conclusions: As compared to single episode depressions, recurrent depression was associated with greater symptom severity and illness characteristics suggestive of greater underlying risk, but not other demographic characteristics than age. Risk for recurrence appeared to be distinct from chronic depression. A subset of chronic first episode patients may lack the capacity to remit and may therefore be distinct from those with recurrent episodes.
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- 2006
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43. Clinical and demographic features of atypical depression in outpatients with major depressive disorder: preliminary findings from STAR*D.
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Novick JS, Stewart JW, Wisniewski SR, Cook IA, Manev R, Nierenberg AA, Rosenbaum JF, Shores-Wilson K, Balasubramani GK, Biggs MM, Zisook S, and Rush AJ
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- Adult, Citalopram, Cognitive Behavioral Therapy, Combined Modality Therapy, Depressive Disorder, Major classification, Diagnostic and Statistical Manual of Mental Disorders, Female, Humans, Male, Odds Ratio, Personality Inventory statistics & numerical data, Selective Serotonin Reuptake Inhibitors therapeutic use, Treatment Outcome, Ambulatory Care, Depressive Disorder, Major diagnosis, Depressive Disorder, Major therapy, Psychiatric Status Rating Scales statistics & numerical data
- Abstract
Objective: To determine the frequency and demographic and clinical characteristics of depression with atypical features in a broadly representative sample of outpatients., Method: Data derived from the first 1500 patients with DSM-IV major depressive disorder enrolled in the Sequenced Treatment Alternatives to Relieve Depression trial at 41 primary care and nonresearch psychiatric outpatient clinics. An algorithm based on the 30-item Inventory of Depressive Symptomatology-Clinician Rating (IDS-C30) determined presence or absence of depression with atypical features. Odds ratios determined whether a variety of demographic and clinical parameters differed between patients meeting and not meeting atypical criteria., Results: Over 18% of the sample met criteria for atypical features based on items from the IDS-C30. The atypical group was more likely to be female and have an earlier age at onset, greater comorbidity with anxiety symptoms, and greater symptom severity compared with the nonatypical group., Conclusion: Previously identified features of atypical depression were confirmed in this large and broadly representative, nonresearch clinical population.
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- 2005
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44. Comorbid psychiatric disorders in depressed outpatients: demographic and clinical features.
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Rush AJ, Zimmerman M, Wisniewski SR, Fava M, Hollon SD, Warden D, Biggs MM, Shores-Wilson K, Shelton RC, Luther JF, Thomas B, and Trivedi MH
- Subjects
- Adult, Comorbidity, Cross-Sectional Studies, Female, Humans, Male, Mental Disorders complications, Prevalence, Psychiatric Status Rating Scales, Severity of Illness Index, Depressive Disorder, Major complications, Depressive Disorder, Major psychology, Mental Disorders epidemiology, Mental Disorders etiology
- Abstract
Background: This study evaluated the clinical and sociodemographic features associated with various degrees of concurrent comorbidity in adult outpatients with nonpsychotic major depressive disorder (MDD)., Methods: Outpatients enrolled in the STAR*D trial completed the Psychiatric Diagnostic Screening Questionnaire (PDSQ). An a priori 90% specificity threshold was set for PDSQ responses to ascertain the presence of 11 different concurrent DSM-IV Axis I disorders., Results: Of 1376 outpatients, 38.2% had no concurrent comorbidities, while 25.6% suffered one, 16.1% suffered two, and 20.2% suffered three or more comorbid conditions. Altogether, 29.3% met threshold for social anxiety disorder, 20.8% for generalized anxiety disorder, 18.8% for posttraumatic stress disorder, 12.4% for bulimia, 11.9% for alcohol abuse/dependence, 13.4% for obsessive-compulsive disorder, 11.1% for panic disorder, 9.4% for agoraphobia, 7.3% for drug abuse/dependence, 3.7% for hypochondriasis, and 2.2% for somatoform disorder. Those with more concurrent Axis I conditions had earlier ages at first onset of MDD, longer histories of MDD, greater depressive symptom severity, more general medical comorbidity (even though they were younger than those with fewer comorbid conditions), poorer physical and mental function, health perceptions, and life satisfaction; and were more likely to be seen in primary care settings., Limitations: Participants had to meet entry criteria for STAR*D. Ascertainment of comorbid conditions was not based on a structured interview., Conclusions: Concurrent Axis I conditions (most often anxiety disorders) are very common with MDD. Greater numbers of concurrent comorbid conditions were associated with increased severity, morbidity, and chronicity of their MDD.
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- 2005
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45. Brief psychiatric rating scale expanded version: How do new items affect factor structure?
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Velligan D, Prihoda T, Dennehy E, Biggs M, Shores-Wilson K, Crismon ML, Rush AJ, Miller A, Suppes T, Trivedi M, Kashner TM, Witte B, Toprac M, Carmody T, Chiles J, and Shon S
- Subjects
- Adult, Algorithms, Factor Analysis, Statistical, Female, Humans, Male, Severity of Illness Index, Brief Psychiatric Rating Scale, Mental Disorders diagnosis
- Abstract
Our goal was to suggest a factor structure for the Brief Psychiatric Rating Scale Expanded Version (BPRS-E) based upon a large and diverse sample and to determine which of the new items improved the factors derived from the 18-item version of the scale that have been used in clinical research for decades. We investigated the consistency of our proposed model over time and across demographic groups. As part of the Texas Medication Algorithm Project, the BPRS-E was administered to a total of 1440 psychiatric outpatients in three different diagnostic groups on multiple occasions. The sample was randomly split so that exploratory factor analysis could be done with the first half, and the model could be confirmed on the second half. A four-factor structure including factors assessing depression/anxiety, psychosis, negative symptoms, and activation was found. For each factor, we specify items in the expanded version that added to the breadth of the commonly used clinical factors while improving or maintaining goodness of fit and reliability. The final model proposed was consistent over time and across diagnosis, phase of illness, age, gender, ethnicity, and level of education. The BPRS-E has a stable four-factor structure, making it useful as a clinical outcome measure.
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- 2005
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46. Substance use disorder comorbidity in major depressive disorder: an exploratory analysis of the Sequenced Treatment Alternatives to Relieve Depression cohort.
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Davis LL, Rush JA, Wisniewski SR, Rice K, Cassano P, Jewell ME, Biggs MM, Shores-Wilson K, Balasubramani GK, Husain MM, Quitkin FM, and McGrath PJ
- Subjects
- Adult, Alcoholism diagnosis, Alcoholism rehabilitation, Ambulatory Care, Antidepressive Agents adverse effects, Antidepressive Agents therapeutic use, Bupropion adverse effects, Bupropion therapeutic use, Buspirone adverse effects, Buspirone therapeutic use, Citalopram adverse effects, Citalopram therapeutic use, Cognitive Behavioral Therapy, Comorbidity, Cyclohexanols adverse effects, Cyclohexanols therapeutic use, Depressive Disorder, Major diagnosis, Diagnosis, Differential, Follow-Up Studies, Humans, Male, Middle Aged, Personality Assessment, Personality Inventory, Risk, Sertraline adverse effects, Sertraline therapeutic use, Substance-Related Disorders diagnosis, Suicide, Attempted psychology, Suicide, Attempted statistics & numerical data, Treatment Outcome, Venlafaxine Hydrochloride, Alcoholism epidemiology, Depressive Disorder, Major epidemiology, Depressive Disorder, Major rehabilitation, Illicit Drugs, Substance-Related Disorders epidemiology, Substance-Related Disorders rehabilitation
- Abstract
Patients with major depressive disorder (MDD) often present with concurrent substance use disorders (SUD) involving alcohol and/or illicit drugs. This analysis compares the depressive symptomatic presentation and a range of clinical and demographic features of patients with MDD and concurrent SUD symptoms vs those without SUD symptoms, to clarify how these two differ and to determine whether concurrent SUD symptoms may alter the clinical presentation of MDD. The first 1500 outpatients with nonpsychotic MDD enrolled in the Sequenced Treatment Alternatives to Relieve Depression study were divided into those with and without concurrent SUD symptoms as ascertained by a self-report instrument, the Psychiatric Diagnostic Screening Questionnaire (PDSQ). Of the 1484 cases with completed baseline PDSQ, 28% (n = 419) of patients with MDD were found to endorse symptoms consistent with current SUD. Patients with symptoms consistent with SUD were more likely to be men (P < .0001), to be either divorced or never married (P = .018), to have a younger age of onset of depression (P = .014), and to have a higher rate of previous suicide attempts (P = .014) than those without SUD symptoms. Patients with major depressive disorder who have symptoms consistent with SUD endorsed greater functional impairment attributable to their illness than those without concurrent SUD symptoms (P = .0111). The presence of SUD symptoms did not alter the overall depressive symptom pattern of presentation, except that the dual-diagnosed patients had higher levels of hypersomnia (P = .006), anxious mood (P = .047), and suicidal ideation (P = .036) compared to those without SUD symptoms. In conclusion, gender, marital status, age of onset of major depression, functional impairment, and suicide risk factors differ in depressed patients with concurrent SUD symptoms compared to those without SUD comorbidity.
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- 2005
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47. A brief cognitive assessment for use with schizophrenia patients in community clinics.
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Velligan DI, DiCocco M, Bow-Thomas CC, Cadle C, Glahn DC, Miller AL, Biggs MM, Shores-Wilson K, McKenzie CA, and Crismon ML
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- Adult, Algorithms, Antipsychotic Agents therapeutic use, Female, Humans, Male, Reproducibility of Results, Schizophrenia diagnosis, Schizophrenia drug therapy, Severity of Illness Index, Time Factors, Ambulatory Care Facilities, Cognition Disorders diagnosis, Cognition Disorders etiology, Community Health Services, Neuropsychological Tests, Schizophrenia complications
- Abstract
Cognitive impairment is a prominent feature of schizophrenia. The availability of very brief measures may increase the use of cognitive assessment in routine care settings. We examined the reliability and validity of the brief cognitive assessment (BCA), a battery that takes approximately 15 min to administer and score, and that was designed to be sensitive to changes in cognition with novel antipsychotics. The BCA was administered to 340 outpatients on two occasions, 3 months apart. A sub-sample of subjects received a full battery of cognitive tests (n=97) and additional measures of functional outcome. Results indicated that the BCA had very good test-retest reliability and inter-item consistency. Moreover, the BCA was strongly correlated with a comprehensive battery (r=0.72; p<0.0001) which took 8 to 10 times longer to administer. Finally, both cognitive batteries were correlated similarly with measures of community functioning. Changes over time for individual patients can be interpreted in the context of normative data available for each test in the BCA. The data provide preliminary evidence for the reliability and validity of the BCA. Further studies examining the utility of the BCA for tracking changes in cognitive functioning with treatment are encouraged.
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- 2004
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48. Clinical results for patients with major depressive disorder in the Texas Medication Algorithm Project.
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Trivedi MH, Rush AJ, Crismon ML, Kashner TM, Toprac MG, Carmody TJ, Key T, Biggs MM, Shores-Wilson K, Witte B, Suppes T, Miller AL, Altshuler KZ, and Shon SP
- Subjects
- Adult, Aged, Antidepressive Agents therapeutic use, Clinical Protocols, Combined Modality Therapy, Community Mental Health Centers, Decision Trees, Depressive Disorder diagnosis, Depressive Disorder economics, Drug Administration Schedule, Electroconvulsive Therapy, Female, Health Care Costs, Humans, Male, Middle Aged, Psychotropic Drugs economics, Severity of Illness Index, Surveys and Questionnaires, Texas, Treatment Outcome, Algorithms, Depressive Disorder drug therapy, Psychotropic Drugs therapeutic use
- Abstract
Context: The Texas Medication Algorithm Project is an evaluation of an algorithm-based disease management program for the treatment of the self-declared persistently and seriously mentally ill in the public mental health sector., Objective: To present clinical outcomes for patients with major depressive disorder (MDD) during 12-month algorithm-guided treatment (ALGO) compared with treatment as usual (TAU)., Design: Effectiveness, intent-to-treat, prospective trial comparing patient outcomes in clinics offering ALGO with matched clinics offering TAU., Setting: Four ALGO clinics, 6 TAU clinics, and 4 clinics that offer TAU to patients with MDD but provide ALGO for schizophrenia or bipolar disorder. Patients Male and female outpatients with a clinical diagnosis of MDD (psychotic or nonpsychotic) were divided into ALGO and TAU groups. The ALGO group included patients who required an antidepressant medication change or were starting antidepressant therapy. The TAU group initially met the same criteria, but because medication changes were made less frequently in the TAU group, patients were also recruited if their Brief Psychiatric Rating Scale total score was higher than the median for that clinic's routine quarterly evaluation of each patient., Main Outcome Measures: Primary outcomes included (1) symptoms measured by the 30-item Inventory of Depressive Symptomatology-Clinician-Rated scale (IDS-C(30)) and (2) function measured by the Mental Health Summary score of the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12) obtained every 3 months. A secondary outcome was the 30-item Inventory of Depressive Symptomatology-Self-Report scale (IDS-SR(30))., Results: All patients improved during the study (P<.001), but ALGO patients had significantly greater symptom reduction on both the IDS-C(30) and IDS-SR(30) compared with TAU. ALGO was also associated with significantly greater improvement in the SF-12 mental health score (P =.046) than TAU., Conclusion: The ALGO intervention package during 1 year was superior to TAU for patients with MDD based on clinician-rated and self-reported symptoms and overall mental functioning.
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- 2004
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49. One-year clinical outcomes of depressed public sector outpatients: a benchmark for subsequent studies.
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Rush AJ, Trivedi M, Carmody TJ, Biggs MM, Shores-Wilson K, Ibrahim H, and Crismon ML
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- Adult, Algorithms, Antidepressive Agents therapeutic use, Benchmarking, Community Mental Health Services statistics & numerical data, Female, Follow-Up Studies, Humans, Logistic Models, Male, Middle Aged, Prospective Studies, Public Sector, Research Design, Severity of Illness Index, Texas, Treatment Outcome, Depressive Disorder, Major therapy, Outpatients psychology, Patient Education as Topic methods
- Abstract
Background: The symptomatic outcomes of a cohort of public mental health sector depressed outpatients treated for 1 year are described to provide a benchmark for future long-term trials. Baseline moderators of outcome were evaluated., Methods: Outpatients with nonpsychotic major depressive disorder (n = 118) scoring >/=30 on the 30-item Inventory of Depressive Symptomatology-Clinician Rating (IDS-C(30)) were treated with a medication algorithm and patient/family education package. Response and remission rates were assessed every 3 months with the IDS-C(30). Logistic regression analyses evaluated several baseline features in relation to outcome., Results: While response and remission rates increased from 3 to 12 months, the 1-year last observation carried forward (LOCF) response (26.3%) and remission (11.0%) rates were not impressive (sustained response = 14.4%; sustained remission = 5.1%). Younger patients and those with full-time employment (at baseline) were more likely to respond. A shorter length of illness tended to be associated with higher response and remission rates (p <.10). Results are generalizable to public sector patients with substantial socioeconomic, general medical, and educational disadvantages who were sufficiently depressed to recommend a change in antidepressant medication., Conclusions: Response and remission rates were modest when compared with outcomes in shorter duration efficacy trials in depressed outpatients with less chronicity, fewer concurrent general medical conditions, and less treatment resistance. Results support the need for more powerful treatments and/or the better delivery of available treatments.
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- 2004
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50. Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D).
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Wisniewski SR, Stegman D, Trivedi M, Husain MM, Eng H, Shores-Wilson K, Luther J, Biggs MM, Burroughs D, Ritz AL, Fava M, Quitkin F, and Rush AJ
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- Communication, Complementary Therapies, Data Collection, Endpoint Determination, Feasibility Studies, Humans, Multicenter Studies as Topic, Patient Dropouts, Patient Selection, Prospective Studies, Randomized Controlled Trials as Topic, Reproducibility of Results, Sample Size, Clinical Trials as Topic methods, Depressive Disorder therapy, Research Design
- Abstract
In large multi-site trials, a feasibility or pilot study can be crucial to test the functionality of all aspects of conducting the study prior to the initiation of the formal study. A feasibility trial was conducted for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Project, a multi-site, prospective, sequentially randomized, clinical trial of outpatients with nonpsychotic major depressive disorder. From 14 December 2000 to 8 June 2001, 42 patients were screened for enrollment into the STAR*D Feasibility Trial. Twenty-four patients who were eligible and consented to participate were treated with citalopram for up to 12 weeks. During the course of this trial, issues were raised that resulted in modifications to the study procedures. Modifications made as a result of this trial affected four domains: (1) communication, (2) patient and provider burden, (3) data collection forms, and (4) recruitment and retention of subjects. This paper describes what was learned during the STAR*D Feasibility Trial so researchers planning to conduct similar trials can learn the practical issues related to conducting such a research project. While the information gathered was useful, it did delay the initiation of the formal trial. We view this cost as an investment in the development of overall study procedures that should lead to a stronger study.
- Published
- 2004
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