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Evidence suggests that parental marital discord contributes to the development of internalizing and externalizing symptoms in children and adolescents. Few studies, however, have examined the association between parental marital discord and youth's response to treatment. The present study examined the impact of interparental discord on treatment response in a randomized control trial of adolescents with major depression enrolled in the Treatment for Adolescents with Depression Study (TADS). Participants were 260 adolescents from two-parent households randomly assigned to one of four treatment groups: fluoxetine (FLX), cognitive behavior therapy (CBT), their combination (COMB), or placebo (PBO). Logistic regressions revealed that parental marital discord interacted with youth gender and co-morbid oppositionality symptoms to predict group differences in treatment response. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this report was to summarize the key clinical messages from the Treatment for Adolescents with Depression Study (TADS). Methods: TADS is a National Institute of Mental Health (NIMH)-funded randomized controlled trial designed to evaluate the relative effectiveness of fluoxetine, cognitive-behavioral therapy (CBT), and the combination of fluoxetine plus CBT across acute treatment, maintenance treatment, and naturalistic follow-up periods among adolescents with major depressive disorder. Results: Findings revealed that 6 to 9 months of combined fluoxetine plus CBT should be the modal treatment from a public health perspective as well as to maximize benefits and minimize harms for individual patients. Conclusion: The combination of fluoxetine and CBT appears to be superior to both CBT monotherapy and fluoxetine monotherapy as a treatment for moderate to severe major depressive disorder in adolescents. [ABSTRACT FROM AUTHOR]

The effect of readiness to change on treatment outcome was examined among 332 adolescents (46% male, 74% Caucasian), ages 12 through 17 years (M = 14.6, SD = 1.5), with major depressive disorder who were participating in the Treatment for Adolescents With Depression Study (TADS). TADS is a randomized clinical trial comparing the effectiveness of fluoxetine (an antidepressant medication), cognitive-behavioral therapy, their combination, and a pill placebo. An abbreviated Stages of Change Questionnaire was used to obtain 4 readiness to change scores: precontemplation, contemplation, action, and maintenance. The association between each readiness score and depression severity across 12 weeks of acute treatment for depression, as measured by the Children's Depression Rating Scale-Revised, was examined. Although treatment response was not moderated by any of the readiness scores, baseline action scores predicted outcome: Higher action scores were associated with better outcome regardless of treatment modality. Furthermore, treatment effects were mediated by change in action scores during the first 6 weeks of treatment, with increases in action scores related to greater improvement in depression. Assessing readiness to change may have implications for tailoring treatments for depressed adolescents. [ABSTRACT FROM AUTHOR]

The article provides information on a study that evaluated the Treatment for Adolescents with Depression Study (TADS) database to identify potential predictors and antecedents of suicidal events (attempts and ideation). TADS was a 36-week randomized controlled trial of fluoxetine, cognitive-behavioral therapy, and their combination for the treatment of adolescents with major depressive disorders.

Background: Factors that distinguish depressed individuals who become hopeless from those who do not are poorly understood. Method: In this study, predictors of hopelessness were examined in a sample of 439 clinically depressed adolescents participating in the Treatment for Adolescents with Depression Study (TADS). The total score of the Beck Hopelessness Scale (BHS) was used to assess hopelessness at baseline. Multiple regression and logistic regression analyses were conducted to evaluate the extent to which variables were associated with hopelessness and determine which cluster of measures best predicted clinically significantly hopelessness. Results: Hopelessness was associated with greater depression severity, poor social problem-solving, cognitive distortions, and family conflict. View of self, view of the world, internal attributional style, need for social approval, positive problem-solving orientation, and family problems consistently emerged as the best predictors of hopelessness in depressed youth. Conclusions: Cognitive and familial factors predict those depressed youth who have high levels of hopelessness. [ABSTRACT FROM AUTHOR]

Objective: While the evidence base for treatments for adolescent depression is building, little is known about the relative efficiency of such treatments. Treatment costs are a relevant concern given the competing demands on family and health care budgets. The authors evaluated the cost-effectiveness of three active treatments among adolescents with major depressive disorder. Method: Volunteers (N=439) ages 12 to 18 with a primary diagnosis of major depressive disorder participated in a randomized, controlled trial conducted at 13 U.S. academic and community clinics from 2000 to 2004. Subjects included those participants who did not drop out and had evaluable outcome and cost data at 12 weeks (N=369). Subjects were randomly assigned to 12 weeks of either fluoxetine alone (10-40 mg/day), CBT alone, CBT combined with fluoxetine (10- 40 mg/day), or placebo (equivalent to 10- 40 mg/day). Both placebo and fluoxetine were administered double-blind; CBT alone and CBT in combination with fluoxetine were administered unblinded. Societal cost per unit of improvement on the Children's Depression Rating Scale-Revised and cost per quality-adjusted life year (QALY) were compared. Results: Results ranged from an incre- mental cost over placebo of $24,000 per QALY for treatment with fluoxetine to $123,000 per QALY for combination therapy treatment. The cost-effectiveness ratio for CBT treatment was not evaluable due to negative clinical effects. The models were robust on a variety of assumptions. Conclusions: Both fluoxetirie and combination therapy are at least as cost-effective in the short-term as other treatments commonly used in primary care (using a threshold of $1 25,000/QALY). Fluoxetine is more cost-effective than combination therapy after 12 weeks of treatment. [ABSTRACT FROM AUTHOR]

The article reports on the study of the response of adolescents with major depressive disorder on continuation and maintenance treatments. It aims to examine the rates of achieving and maintaining sustained response during continuation and maintenance treatments of adolescents with depression. It evaluates the fluoxetine (FLX), cognitive behavioral therapy (CBT), and FLX/CBT combination (COMB) of 439 adolescents with major depressive disorder in thirteen US psychiatric clinics. It also covers the three stages of depression treatment namely acute, continuation and maintenance treatment.

A latent profile analysis was conducted on the co-occurring symptoms of 423 adolescents diagnosed with major depressive disorder as part of the Treatment for Adolescents with Depression Study (TADS), a multisite, randomized treatment trial. The participants had a mean (SD) age of 14.6 (1.5) years; of the sample, 45.6% was male and 73.8% was white. Scores on the primary subscales of Conners' Parent Rating Scale—Revised were used as indicators in the analysis. Five classes of symptoms best described the clinical presentation of adolescents enrolled in the TADS. Of the adolescents in the sample, 80% were assigned to classes with clinically significant elevations on I or more subscales of the Children's Depression Rating Scale—Revised. The 5 classes met empirical criteria for distinctiveness and were validated against clinical diagnoses, child-rated symptoms, and clinician-rated functional impairment. The findings are consistent with prior studies that showed a high rate of co-occurring symptoms among depressed adolescents. The discussion focuses on understanding subtypes and comorbidity in adolescent depression as well as the implications for treatment and for prevention. [ABSTRACT FROM AUTHOR]

The Treatment for Adolescents With Depression Study (TADS) is an NIMH-supported multisite clinical trial that compares the effectiveness of a depression-specific cognitive behavioral therapy (CBT), medication management with fluoxetine (FLX), the combination of CBT and FLX (COMB), and medical management with pill placebo (PBO). TADS was specifically designed as a comprehensive effectiveness study, able to answer clinically meaningful questions by including a broad and representative sample of depressed teens, delivering treatment at both tertiary medical centers and community clinics, and assessing functional as well as symptomatic outcomes. This report supports the importance of conducting clinical trials in youth with depression to bridge the gap between science and practice. [Copyright &y& Elsevier]

Presents a letter to the editor about the treatment for adolescents with depression study (TADS) and criticizes Jureidini et al for errors in their article.

Presents a letter to the editor in reply to psycho therapeutic treatment for depressed youngsters published in the 2005 issue of the "Journal of the American Academy of child and Adolescent Psychiatry."

Objective: To assess acute and longer-term safety of duloxetine in the treatment of children and adolescents with major depressive disorder (MDD), a pooled analysis of data from two completed randomized, double-blind, multicenter, phase 3, placebo- and active-controlled trials was undertaken. In these studies, neither duloxetine (investigational drug) nor fluoxetine (active control) demonstrated a statistically significant improvement compared with placebo on the primary efficacy measure. Methods: Patients ages 7-17 years with MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) received duloxetine ( n=341), fluoxetine ( n=234), or placebo ( n=225) for 10 week acute and 26 week extended (duloxetine or fluoxetine only) treatments. Safety measures included treatment-emergent adverse events (TEAEs), the Columbia-Suicide Severity Rating Scale, vital signs, electrocardiograms, laboratory samples, and growth (height and weight) assessments. Results: Significantly more patients discontinued because of adverse events during duloxetine (8.2%) treatment than during placebo (3.1%) treatment ( p≤0.05). TEAEs in >10% of duloxetine-treated patients were headache and nausea. No completed suicides or deaths occurred. During acute treatment, 6.6% of duloxetine-, 8.0% of fluoxetine-, and 8.2% of placebo-treated patients had worsening suicidal ideation from baseline. Among patients initially randomized to duloxetine or fluoxetine who had suicidal ideation at study baseline, 81% of duloxetine- and 77% of fluoxetine-treated patients had improvements in suicidal ideation at end-point in the 36-week studies. Suicidal behavior occurred in two fluoxetine-treated patients and one placebo-treated patient during acute treatment, and in seven duloxetine-treated patients and one fluoxetine-treated patient during extended treatment. Duloxetine-treated patients had a mean pulse increase of ∼3 beats per minute, and mean blood pressure (both systolic and diastolic) increases of <2.0 mm Hg at week 36. Weight decrease (≥3.5%) during acute treatment occurred with statistically ( p≤0.05) greater frequency for both the duloxetine (11.4%) and fluoxetine (11.5%) groups versus the placebo (5.5%) group; however, mean weight increase occurred for both duloxetine and fluoxetine groups during extended treatment. Conclusion: Results from this pooled analysis of two studies were consistent with the known safety and tolerability profile of duloxetine. Clinical Trial Registry Numbers: NCT00849901 and NCT00849693. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to evaluate the efficacy and safety of duloxetine flexible dose in children (7-11 years) and adolescents (12-17 years) with major depressive disorder (MDD). Methods: Patients ( n=337) in this 36 week study (10 week acute and 26 week extension treatment) received duloxetine (60-120 mg once daily [QD], n=117), fluoxetine (20-40 mg QD, n=117), or placebo ( n=103). Measures included: Children's Depression Rating Scale-Revised (CDRS-R), treatment-emergent adverse events (TEAEs), and Columbia-Suicide Severity Rating Scale (C-SSRS). Results: Neither active drug (duloxetine or fluoxetine) separated significantly ( p<0.05) from placebo on mean change from baseline to end-point (10 weeks) on the CDRS-R total score. There were no significant differences between the duloxetine or fluoxetine groups compared with placebo on serious AEs (SAEs), total TEAEs, or discontinuation for AE during acute treatment. There were no completed suicides or deaths, and no clinically significant electrocardiogram (ECG) abnormalities observed during the study. One fluoxetine and one duloxetine patient experienced alanine aminotransferase (ALT) three or more times the upper limit of normal, which resolved during the study. A total of 8 (7.1%) duloxetine patients, 7 (6.8%) placebo patients, and 9 (8.0%) fluoxetine patients had worsening of suicidal ideation from baseline during acute treatment. Of the patients with suicidal ideation at baseline, 15/19 (79%) duloxetine, 19/19 (100%) placebo, and 16/19 (84%) fluoxetine had improvement in suicidal ideation at end-point during acute treatment. One duloxetine and two fluoxetine patients had treatment-emergent suicidal behavior during the 36 week study. Conclusion: Trial results were inconclusive, as neither the investigational drug (duloxetine) nor the active control (fluoxetine) separated from placebo on the CDRS-R at 10 weeks. No new duloxetine safety signals were identified relative to those seen in adults. Clinical Trial Registry Number: NCT00849901 [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to evaluate the efficacy and safety of duloxetine fixed dose in the treatment of children (7-11 years) and adolescents (12-17 years) with major depressive disorder (MDD). Methods: Patients ( n=463) in this 36 week study (10 week acute and 26 week extension treatment) received duloxetine 60 mg QD ( n=108), duloxetine 30 mg QD ( n=116), fluoxetine 20 mg QD ( n=117, active control), or placebo ( n=122). Measures included: Children's Depression Rating Scale-Revised (CDRS-R), treatment-emergent adverse events (TEAEs), and Columbia-Suicide Severity Rating Scale (C-SSRS). Results: Neither active drug (duloxetine or fluoxetine) separated significantly ( p<0.05) from placebo on mean change from baseline to end-point (10 weeks) on the CDRS-R total score. Total TEAEs and discontinuation for AEs were significantly ( p<0.05) higher only for the duloxetine 60 mg group versus the placebo group during acute treatment. No clinically significant electrocardiogram (ECG) or laboratory abnormalities were observed, and no completed suicides or deaths occurred during the study. A total of 7 (6.7%) duloxetine 60 mg, 6 (5.2%) duloxetine 30 mg, 9 (8.0%) fluoxetine, and 11 (9.4%) placebo patients had worsening of suicidal ideation from baseline during acute treatment. Of the patients with suicidal ideation at baseline, 13/16 (81%) duloxetine 60 mg, 16/17 (94%) duloxetine 30 mg, 11/16 (69%) fluoxetine, and 13/15 (87%) placebo had improvement in suicidal ideation at end-point during acute treatment. One fluoxetine, one placebo, and six duloxetine patients had treatment-emergent suicidal behavior during the 36 week study. Conclusions: Trial results were inconclusive, as neither the investigational drug (duloxetine) nor the active control (fluoxetine) separated from placebo on the CDRS-R at 10 weeks. No new duloxetine safety signals were identified relative to those seen in adults. Clinical Trial Registry Number (): NCT00849693 [ABSTRACT FROM AUTHOR]

During childhood and adolescence, physiological, psychological, and behavioral processes strongly promote weight gain and increased appetite while also inhibiting weight loss and decreased appetite. The Diagnostic and Statistical Manual-IV (DSM-IV) treats both weight-gain/increased-appetite and weight-loss/decreased-appetite as symptoms of major depression during these developmental periods, despite the fact that one complements typical development and the other opposes it. To disentangle the developmental versus pathological correlates of weight and appetite disturbance in younger age groups, the current study examined symptoms of depression in an aggregated sample of 2307 children and adolescents, 47.25% of whom met criteria for major depressive disorder. A multigroup, multidimensional item response theory model generated three key results. First, weight loss and decreased appetite loaded strongly onto a general depression dimension; in contrast, weight gain and increased appetite did not. Instead, weight gain and increased appetite loaded onto a separate dimension that did not correlate strongly with general depression. Second, inclusion or exclusion of weight gain and increased appetite affected neither the nature of the general depression dimension nor the fidelity of major depressive disorder diagnosis. Third, the general depression dimension and the weight-gain/ increased-appetite dimension showed different patterns across age and gender. In child and adolescent populations, these results call into question the utility of weight gain and increased appetite as indicators of depression. This has serious implications for the diagnostic criteria of depression in children and adolescents. These findings inform a revision of the DSM, with implications for the diagnosis of depression in this age group and for research on depression. [ABSTRACT FROM AUTHOR]

Abstract: The purpose of this report is to examine relations between extreme thinking, as measured by the Dysfunctional Attitudes Scale, and the maintenance of gains among adolescents who participated in the Treatment for Adolescents with Depression Study (TADS). We examine extreme thinking among 327 adolescents (mean age=14.56, 57% female, 75% White) who received cognitive behavior therapy (CBT), fluoxetine (FLX), or a combination of CBT and FLX (COMB). Among those who met remission status on the Children’s Depression Rating Scale – Revised (CDRS-R≤28; 56 at week 12, 79 at week 18) extreme thinking did not predict failure to maintain remission. This is in contrast to findings with depressed adults. Treatment influenced level of extreme thinking, and this appeared to be driven by greater endorsement of positively valenced beliefs as opposed to a decrease in negatively valenced beliefs. Developmental or investigation characteristics may account for the discrepancy in findings. [ABSTRACT FROM AUTHOR]

The article presents a study on the effect of childhood trauma on teenagers with major depressive disorder involved in the Treatment for Adolescents with Depression Study (TADS) in the U.S. The effectiveness of cognitive behavioral therapy (CBT), fluoxetine (FLX), their combination (COMB), and placebo (PBO) were analyzed. Results said that those with history of sexual abuse treated with COMB, FLX and PBO had significant improvement on the Children's Depression Rating Scale-Revised (CDRS-R).

The article offers a comparison of the cost-effectiveness of three active interventions for major depression in adolescents after 36 weeks of treatment in the Treatment of Adolescents with Depression Study. It depicts that cost-effectiveness acceptability curves imply that combination treatment is potentially more cost-effective compared to fluoxetine at 36 weeks. It shows that findings support the use of combination treatment in adolescents with depression over monotherapy.

Objective: To examine factors associated with eligibility and randomization and consider the efficiency of recruitment methods.Method: Adolescents, ages 12 to 17 years, were telephone screened (N = 2,804) followed by in-person evaluation (N = 1,088) for the Treatment for Adolescents With Depression Study. Separate logistic regression models, controlling for site, examined whether sex, age, race, or source of recruitment was associated with eligibility, providing written consent, or randomization. Efficiency was calculated from the number of completed telephone screens per each enrolled participant.Results: Older adolescents were less likely to be eligible at telephone screening (odds ratio [OR] 0.81). Regardless of race, eligible adolescents who were referred by a professional had higher odds of presenting in-person for consent (OR 1.56). African Americans had statistically lower odds of providing consent (OR 0.67), particularly if recruited by advertisement (OR 0.54). Females were more likely to be diagnosed with major depressive disorder (OR 1.69). No significant differences were found between randomized participants and eligible adolescents who withdrew from the study before randomization.Conclusions: These findings underscore the importance of using multiple strategies to recruit adolescents for clinical trial participation and enhancing sensitivity to cultural variations, especially when reaching out to depressed African Americans. [ABSTRACT FROM AUTHOR]

Objective: To describe a manual-based intervention to address clinical crises and retain participants in the Treatment for Adolescents With Depression Study (TADS).Method: The use of adjunct services for attrition prevention (ASAP) is described for adolescents (ages 12-17 years) during the 12-week acute treatment in TADS, from 2000 to 2003. Logistic regression, controlling for site, was used to predict use.Results: Of 439 enrolled participants, 17.8% (n = 78) used ASAP primarily for suicidality or worsening of depression. Of these, 46.2% continued in their assigned treatment through week 12, 47.4% received out-of-protocol treatment but continued participating in assessments, and 10.3% withdrew consent, including 3 who terminated treatment and withdrew consent on the same date. ASAP use did not differ between treatments (p =.97) and typically occurred early in treatment. At the end of the 12 weeks, 37.2% of participants using ASAP remained in their assigned treatment, although 80.8% continued participating in assessments. ASAP was associated with, at baseline, a higher severity of depression (p <.01), substance use (p <.01), and precontemplation level of change (p <.02).Conclusions: ASAP may be useful to retain adolescent participants and as a safety intervention in placebo-controlled trials. In clinical practice ASAP-like procedures may be useful to encourage adherence in patients engaging in long-term treatment. Clinical trial registration information-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006286. [ABSTRACT FROM AUTHOR]