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3. A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials

Author

Sforzini, Luca, Worrell, Courtney, Kose, Melisa, Anderson, Ian M, Aouizerate, Bruno, Arolt, Volker, Bauer, Michael, Baune, Bernhard T, Blier, Pierre, Cleare, Anthony J, Cowen, Philip J, Dinan, Timothy G, Fagiolini, Andrea, Ferrier, I Nicol, Hegerl, Ulrich, Krystal, Andrew D, Leboyer, Marion, McAllister-Williams, R Hamish, McIntyre, Roger S, Meyer-Lindenberg, Andreas, Miller, Andrew H, Nemeroff, Charles B, Normann, Claus, Nutt, David, Pallanti, Stefano, Pani, Luca, Penninx, Brenda WJH, Schatzberg, Alan F, Shelton, Richard C, Yatham, Lakshmi N, Young, Allan H, Zahn, Roland, Aislaitner, Georgios, Butlen-Ducuing, Florence, Fletcher, Christine, Haberkamp, Marion, Laughren, Thomas, Mäntylä, Fanni-Laura, Schruers, Koen, Thomson, Andrew, Arteaga-Henríquez, Gara, Benedetti, Francesco, Cash-Gibson, Lucinda, Chae, Woo Ri, De Smedt, Heidi, Gold, Stefan M, Hoogendijk, Witte JG, Mondragón, Valeria Jordán, Maron, Eduard, Martynowicz, Jadwiga, Melloni, Elisa, Otte, Christian, Perez-Fuentes, Gabriela, Poletti, Sara, Schmidt, Mark E, van de Ketterij, Edwin, Woo, Katherine, Flossbach, Yanina, Ramos-Quiroga, J Antoni, Savitz, Adam J, and Pariante, Carmine M

Subjects
Clinical Trials and Supportive Activities, Depression, Clinical Research, Mental Health, Brain Disorders, Serious Mental Illness, Major Depressive Disorder, Good Health and Well Being, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Humans, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Psychiatry
Abstract

Criteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve as operational criteria for future clinical studies, especially if conducted for regulatory purposes. We reviewed the literature and brought together a group of international experts (including clinicians, academics, researchers, employees of pharmaceutical companies, regulatory bodies representatives, and one person with lived experience) to evaluate the state-of-the-art and main controversies regarding the current classification. We then provided recommendations on how to design clinical trials, and on how to guide research in unmet needs and knowledge gaps. This report will feed into one of the main objectives of the EUropean Patient-cEntric clinicAl tRial pLatforms, Innovative Medicines Initiative (EU-PEARL, IMI) MDD project, to design a protocol for platform trials of new medications for TRD/PRD.

Published
2022

8. Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes.

Author

Sisson, Michelle L., Gajos, Jamie M., Wolford-Clevenger, Caitlin, Chichester, Keith R., Hawes, Elizabeth S., Hill, Samantha V., Shelton, Richard C., Hendricks, Peter S., Businelle, Michael S., Carpenter, Matthew J., and Cropsey, Karen L.

Abstract

Objectives: Smoking prevalence remains high among low-income smokers. Understanding processes (eg, withdrawal, craving, motivation) in early smoking cessation is crucially important for designing effective interventions for this population. Methods: This is a secondary analysis of a novel, in-session sampling intervention (ie, In Vivo) as compared with standard care behavioral smoking cessation counseling (SC) among community-dwelling low-income smokers (n = 83). This analysis examined the effect of 5 in-session sampling interventions on cessation-related processes and perceived advantages or disadvantages of nicotine replacement therapy (NRT) products over time using daily diaries. Results: The In Vivo treatment had an early positive impact in terms of decreasing withdrawal symptoms and cravings, and increasing perceived advantages to NRT, with moderate to large effect sizes. Results also showed that the treatment effectively reduced withdrawal symptoms and cravings in-session, with small-to-medium and medium-to-large effect sizes, respectively. In-session reduction of withdrawal symptoms and cravings did not occur for the SC group, with the exception of decreased withdrawal symptoms occurring during week 4. The In Vivo treatment did not impact quit goal, desire to quit, abstinence self-efficacy, perceived difficulty in quitting, motivational engagement, or perceived disadvantages to NRT. The In Vivo group reported less daily cigarette use relative to the SC group, in addition to reporting less cigarette use on days they reported greater combination NRT use. Conclusions: There is preliminary support for this In Vivo treatment over SC in reducing withdrawal, craving, and the number of cigarettes smoked per day, as well as promoting perceived advantages of NRT among low-income smokers. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Response and remission rates during 24 weeks of mood-stabilizing treatment for bipolar depression depending on early non-response

Author

Köhler-Forsberg, Ole, Sloth, Kirstine H., Sylvia, Louisa G., Thase, Michael, Calabrese, Joseph R., Tohen, Mauricio, Bowden, Charles L., McInnis, Melvin, Kocsis, James H., Friedman, Edward S., Ketter, Terence A., McElroy, Susan L., Shelton, Richard C, Iosifescu, Dan V, Ostacher, Michael J., and Nierenberg, Andrew A.

Published
2021
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11. Clinical validation of combinatorial pharmacogenomic testing and single-gene guidelines in predicting psychotropic medication blood levels and clinical outcomes in patients with depression

Author

Rothschild, Anthony J., Parikh, Sagar V., Hain, Daniel, Law, Rebecca, Thase, Michael E., Dunlop, Boadie W., DeBattista, Charles, Conway, Charles R., Forester, Brent P., Shelton, Richard C., Macaluso, Matthew, Brown, Krystal, Lewis, David, Gutin, Alexander, Jablonski, Michael R., and Greden, John F.

Published
2021
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14. Serotonin and Norepinephrine Reuptake Inhibitors

Author

Shelton, Richard C., Barrett, James E., Editor-in-Chief, Flockerzi, Veit, Editorial Board Member, Frohman, Michael A., Editorial Board Member, Geppetti, Pierangelo, Editorial Board Member, Hofmann, Franz B., Editorial Board Member, Michel, Martin C., Editorial Board Member, Page, Clive P., Editorial Board Member, Rosenthal, Walter, Editorial Board Member, Wang, KeWei, Editorial Board Member, Macaluso, Matthew, editor, and Preskorn, Sheldon H., editor

Published
2019
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16. Combinatorial Pharmacogenomic Algorithm is Predictive of Citalopram and Escitalopram Metabolism in Patients with Major Depressive Disorder

Author

Shelton, Richard C., Parikh, Sagar V., Law, Rebecca A., Rothschild, Anthony J., Thase, Michael E., Dunlop, Boadie W., DeBattista, Charles, Conway, Charles R., Forester, Brent P., Macaluso, Matthew, Hain, Daniel T., Aguilar, Aime Lopez, Brown, Krystal, Lewis, David J., Jablonski, Michael R., and Greden, John F.

Published
2020
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17. Familial severe psychiatric history in bipolar disorder and correlation with disease severity and treatment response

Author

Köhler-Forsberg, Ole, Sylvia, Louisa G., Ruberto, Valerie L., Kuperberg, Maya, Shannon, Alec P., Fung, Vicki, Overhage, Lindsay, Calabrese, Joseph R., Thase, Michael, Bowden, Charles L., Shelton, Richard C., McInnis, Melvin, Deckersbach, Thilo, Tohen, Mauricio, Kocsis, James H., Ketter, Terence A., Friedman, Edward S., Iosifescu, Dan V., McElroy, Susan, Ostacher, Michael J, and Nierenberg, Andrew A.

Published
2020
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18. The impact of binge eating behavior on lithium- and quetiapine-associated changes in body weight, body mass index, and waist circumference during 6 months of treatment: Findings from the bipolar CHOICE study

Author

Yaramala, Satyanarayana R., McElroy, Susan L., Geske, Jennifer, Winham, Stacey, Gao, Keming, Reilly-Harrington, Noreen A., Ketter, Terence A., Deckersbach, Thilo, Kinrys, Gustavo, Kamali, Masoud, Sylvia, Louisa G., McInnis, Melvin G., Friedman, Edward S., Thase, Machael E., Kocsis, James H., Tohen, Mauricio, Calabrese, Joseph R., Bowden, Charles L., Shelton, Richard C., Nierenberg, Andrew A., and Bobo, William V.

Published
2020
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19. Bipolar depression and suicidal ideation: Moderators and mediators of a complex relationship

Author

Kamali, Masoud, Reilly-Harrington, Noreen A., Chang, Weilynn C., McInnis, Melvin, McElroy, Susan L., Ketter, Terence A., Shelton, Richard C., Deckersbach, Thilo, Tohen, Mauricio, Kocsis, James H., Calabrese, Joseph R., Gao, Keming, Thase, Michael E., Bowden, Charles L., Kinrys, Gustavo, Bobo, William V., Brody, Benjamin D., Sylvia, Louisa G., Rabideau, Dustin J., and Nierenberg, Andrew A.

Published
2019
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21. Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: A large, patient- and rater-blinded, randomized, controlled study

Author

Greden, John F., Parikh, Sagar V., Rothschild, Anthony J., Thase, Michael E., Dunlop, Boadie W., DeBattista, Charles, Conway, Charles R., Forester, Brent P., Mondimore, Francis M., Shelton, Richard C., Macaluso, Matthew, Li, James, Brown, Krystal, Gilbert, Alexa, Burns, Lindsey, Jablonski, Michael R., and Dechairo, Bryan

Published
2019
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23. Sleep disturbance may impact treatment outcome in bipolar disorder: A preliminary investigation in the context of a large comparative effectiveness trial

Author

Sylvia, Louisa G., Chang, Weilynn C., Kamali, Masoud, Tohen, Mauricio, Kinrys, Gustavo, Deckersbach, Thilo, Calabrese, Joseph R., Thase, Michael E., Reilly-Harrington, Noreen, Bobo, William V., Kocsis, James H., McInnis, Melvin G., Bowden, Charles L., Ketter, Terence A., Friedman, Edward S., Shelton, Richard C., McElroy, Susan L., Gao, Keming, Rabideau, Dustin J., and Nierenberg, Andrew A.

Published
2018
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24. Trajectories of suicidal ideation over 6 months among 482 outpatients with bipolar disorder

Author

Köhler-Forsberg, Ole, Madsen, Trine, Behrendt-Møller, Ida, Sylvia, Louisa, Bowden, Charles L., Gao, Keming, Bobo, William V., Trivedi, Madhukar H., Calabrese, Joseph R., Thase, Michael, Shelton, Richard C., McInnis, Melvin, Tohen, Mauricio, Ketter, Terence A., Friedman, Edward S., Deckersbach, Thilo, McElroy, Susan L., Reilly-Harrington, Noreen A., and Nierenberg, Andrew A.

Published
2017
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27. Anxiety Disorders

Author

Preston, Taylor C., Shelton, Richard C., Fatemi, S. Hossein, editor, and Clayton, Paula J., editor

Published
2016
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28. Comparative effectiveness research trial for antidepressant incomplete and non-responders with treatment resistant depression (ASCERTAIN-TRD) a randomized clinical trial

Author

Papakostas, George I., Trivedi, Madhukar H., Shelton, Richard C., Iosifescu, Dan V., Thase, Michael E., Jha, Manish K., Mathew, Sanjay J., DeBattista, Charles, Dokucu, Mehmet E., Brawman-Mintzer, Olga, Currier, Glenn W., McCall, William Vaughn, Modirrousta, Mandana, Macaluso, Matthew, Bystritsky, Alexander, Rodriguez, Fidel Vila, Nelson, Erik B., Yeung, Albert S., Feeney, Anna, MacGregor, Leslie C., Carmody, Thomas, and Fava, Maurizio

Abstract

Further research is needed to help improve both the standard of care and the outcome for patients with treatment-resistant depression. A particularly critical evidence gap exists with respect to whether pharmacological or non-pharmacological augmentation is superior to antidepressant switch, or vice-versa. The objective of this study was to compare the effectiveness of augmentation with aripiprazole or repetitive transcranial magnetic stimulation versus switching to the antidepressant venlafaxine XR (or duloxetine for those not eligible to receive venlafaxine) for treatment-resistant depression. In this multi-site, 8-week, randomized, open-label study, 278 subjects (196 females and 82 males, mean age 45.6 years (SD 15.3)) with treatment-resistant depression were assigned in a 1:1:1 fashion to treatment with either of these three interventions; 235 subjects completed the study. 260 randomized subjects with at least one post-baseline Montgomery-Asberg Depression Rating (MADRS) assessment were included in the analysis. Repetitive transcranial magnetic stimulation (score change (standard error (se)) = −17.39 (1.3) (p= 0.015) but not aripiprazole augmentation (score change (se) = −14.9 (1.1) (p= 0.069) was superior to switch (score change (se) = −13.22 (1.1)) on the MADRS. Aripiprazole (mean change (se) = −37.79 (2.9) (p= 0.003) but not repetitive transcranial magnetic stimulation augmentation (mean change (se) = −42.96 (3.6) (p= 0.031) was superior to switch (mean change (se) = −34.45 (3.0)) on the symptoms of depression questionnaire. Repetitive transcranial magnetic stimulation augmentation was shown to be more effective than switching antidepressants in treatment-resistant depression on the study primary measure. In light of these findings, clinicians should consider repetitive transcranial magnetic stimulation augmentation early-on for treatment-resistant depression.

Published
2024
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29. Bipolar mixed features – Results from the comparative effectiveness for bipolar disorder (Bipolar CHOICE) study

Author

Tohen, Mauricio, Gold, Alexandra K., Sylvia, Louisa G., Montana, Rebecca E., McElroy, Susan L., Thase, Michael E., Rabideau, Dustin J., Nierenberg, Andrew A., Reilly-Harrington, Noreen A., Friedman, Edward S., Shelton, Richard C., Bowden, Charles L., Singh, Vivek, Deckersbach, Thilo, Ketter, Terence A., Calabrese, Joseph R., Bobo, William V., and McInnis, Melvin G.

Published
2017
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30. Clinical correlates of acute bipolar depressive episode with psychosis

Author

Caldieraro, Marco Antonio, Sylvia, Louisa G., Dufour, Steven, Walsh, Samantha, Janos, Jessica, Rabideau, Dustin J., Kamali, Masoud, McInnis, Melvin G., Bobo, William V., Friedman, Edward S., Gao, Keming, Tohen, Mauricio, Reilly-Harrington, Noreen A., Ketter, Terence A., Calabrese, Joseph R., McElroy, Susan L., Thase, Michael E., Shelton, Richard C., Bowden, Charles L., Kocsis, James H., Deckersbach, Thilo, and Nierenberg, Andrew A.

Published
2017
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37. Tracking medication changes to assess outcomes in comparative effectiveness research: A bipolar CHOICE study

Author

Reilly-Harrington, Noreen A., Sylvia, Louisa G., Rabideau, Dustin J., Gold, Alexandra K., Deckersbach, Thilo, Bowden, Charles L., Bobo, William V., Singh, Vivek, Calabrese, Joseph R., Shelton, Richard C., Friedman, Edward S., Thase, Michael E., Kamali, Masoud, Tohen, Mauricio, McInnis, Melvin G., McElroy, Susan L., Ketter, Terence A., Kocsis, James H., Kinrys, Gustavo, and Nierenberg, Andrew A.

Published
2016
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38. Poor quality of life and functioning in bipolar disorder

Author

Sylvia, Louisa G., Montana, Rebecca E., Deckersbach, Thilo, Thase, Michael E., Tohen, Maurcio, Reilly-Harrington, Noreen, McInnis, Melvin G., Kocsis, James H., Bowden, Charles, Calabrese, Joseph, Gao, Keming, Ketter, Terence, Shelton, Richard C., McElroy, Susan L., Friedman, Edward S., Rabideau, Dustin J., and Nierenberg, Andrew A.

Published
2017
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39. A tool to predict suicidal ideation and behavior in bipolar disorder: The Concise Health Risk Tracking Self-Report

Author

Reilly-Harrington, Noreen A., Shelton, Richard C., Kamali, Masoud, Rabideau, Dustin J., Shesler, Leah W., Trivedi, Madhukar H., McElroy, Susan L., Sylvia, Louisa G., Bowden, Charles L., Ketter, Terence A., Calabrese, Joseph R., Thase, Michael E., Bobo, William V., Deckersbach, Thilo, Tohen, Mauricio, McInnis, Melvin G., Kocsis, James H., Gold, Alexandra K., Singh, Vivek, Finkelstein, Daniel M., Kinrys, Gustavo, and Nierenberg, Andrew A.

Published
2016
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46. Association of exercise with quality of life and mood symptoms in a comparative effectiveness study of bipolar disorder

Author

Sylvia, Louisa G., Friedman, Edward S., Kocsis, James H., Bernstein, Emily E., Brody, Benjamin D., Kinrys, Gustavo, Kemp, David E., Shelton, Richard C., McElroy, Susan L., Bobo, William V., Kamali, Masoud, McInnis, Melvin G., Tohen, Mauricio, Bowden, Charles L., Ketter, Terence A., Deckersbach, Thilo, Calabrese, Joseph R., Thase, Michael E., Reilly-Harrington, Noreen A., Singh, Vivek, Rabideau, Dustin J., and Nierenberg, Andrew A.

Published
2013
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47. Predictors of Patient Cognitive Therapy Skills and Symptom Change in Two Randomized Clinical Trials: The Role of Therapist Adherence and the Therapeutic Alliance

Author

Webb, Christian A., DeRubeis, Robert J., Dimidjian, Sona, Hollon, Steven D., Amsterdam, Jay D., and Shelton, Richard C.

Abstract

Objective: Previous research has found that therapist adherence to concrete, problem-focused cognitive therapy (CT) techniques predicts depressive symptom change (e.g., Feeley, DeRubeis, & Gelfand, 1999). More recently, Strunk, DeRubeis, Chui, and Alvarez (2007) demonstrated that in-session evidence of patients' use of CT skills was related to a lower rate of relapse in the year following CT for depression. The current investigation attempts to integrate and extend these findings within 2 separate samples of patients and therapists. Method: Drawing from the CT samples (N = 105, mean age = 40 years, female = 62%, White = 82%) of 2 published randomized clinical trials of depression treatment, we conducted analyses to examine whether therapist adherence to concrete CT techniques (Collaborative Study Psychotherapy Rating Scale) and the quality of the therapeutic alliance (Working Alliance Inventory) predict patients' use of CT skills (Performance of Cognitive Therapy Strategies) and subsequent Beck Depression Inventory symptom change. Results: Results indicated a differential pattern of prediction in the 2 samples. In one, CT techniques exhibited a stronger association with patient CT skills and symptom change than did the alliance, whereas the reverse pattern emerged in the second sample. A baseline symptom severity x CT techniques interaction indicated that between-study differences in intake depression severity might in part explain the process-outcome differences. Conclusions: The present findings suggest that the nature of the therapy sample examined may moderate process-outcome findings in psychotherapy research. The implications of these results and directions for future research are discussed. (Contains 2 tables and 3 footnotes.)

Published
2012
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48. Two Aspects of the Therapeutic Alliance: Differential Relations with Depressive Symptom Change

Author

Webb, Christian A., Derubeis, Robert J., Amsterdam, Jay D., Shelton, Richard C., Hollon, Steven D., and Dimidjian, Sona

Abstract

Objective: The therapeutic alliance has been linked to symptom change in numerous investigations. Although the alliance is commonly conceptualized as a multidimensional construct, few studies have examined its components separately. The current study explored which components of the alliance are most highly associated with depressive symptom change in cognitive therapy (CT). Method: Data were drawn from 2 published randomized, controlled clinical trials of CT for major depressive disorder (n = 105, mean age = 40 years, female = 62%, White = 82%). We examined the relationslor of 2 factor-analytically derived components of the Working Alliance Inventory (WAI; Horvath & Greenberg, 1986, 1989) with symptom change on the Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996) that occurred either prior to or subsequent to the examined sessions. WAI ratings were obtained at an early and a late session for each therapist-patient dyad. Results: Variation in symptom change subsequent to the early session was significantly related to the WAI factor that assesses therapist-patient agreement on the goals and tasks of therapy but not to a factor assessing the affective bond between therapist and patient. In contrast, both factors, when assessed in a late session, were significantly predicted by prior symptom change. Conclusions: These findings may reflect the importance, in CT, of therapist-patient agreement on the goals and tasks of therapy. In contrast, the bond between therapist and patient may be more of a consequence than a cause of symptom change in CT. The implications of these results and directions for future research are discussed. (Contains 4 footnotes and 1 table.)

Published
2011
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50. Prediction of Response to Medication and Cognitive Therapy in the Treatment of Moderate to Severe Depression

Author

Fournier, Jay C., DeRubeis, Robert J., and Shelton, Richard C.

Abstract

A recent randomized controlled trial found nearly equivalent response rates for antidepressant medications and cognitive therapy in a sample of moderate to severely depressed outpatients. In this article, the authors seek to identify the variables that were associated with response across both treatments as well as variables that predicted superior response in one treatment over the other. The sample consisted of 180 depressed outpatients: 60 of whom were randomly assigned to cognitive therapy; 120 were assigned to antidepressant medications. Treatment was provided for 16 weeks. Chronic depression, older age, and lower intelligence each predicted relatively poor response across both treatments. Three prescriptive variables--marriage, unemployment, and having experienced a greater number of recent life events--were identified, and each predicted superior response to cognitive therapy relative to antidepressant medications. Thus, 6 markers of treatment outcome were identified, each of which might be expected to carry considerable clinical utility. The 3 prognostic variables identify subgroups that might benefit from alternative treatment strategies; the 3 prescriptive variables identify groups who appear to respond particularly well to cognitive therapy. (Contains 3 footnotes, 4 tables, and 4 figures.)

Published
2009
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