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2. A proof-of-concept randomized crossover clinical trial of a first-in-class vasopressin 1a receptor antagonist for PTSD: Design, methods, and recruitment

Author

Difede, JoAnn, McAleavey, Andrew A., Emrich, Mariel, Jick, Adina, Ovalles, Annell, Wyka, Katarzyna, Spielman, Lisa, Olden, Megan, Peskin, Melissa, Becket-Davenport, Colleen, Rubenstein, Amy, Brownstein, Michael J., Damiano, Eve, Itzkowitz, Debra, Lu, Shi-fang, Needell, Nancy J., Kocsis, James H., Gordon-Elliott, Janna S., and Simon, Neal G.

Published
2023
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3. 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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5. 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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6. 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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8. 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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12. 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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13. 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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14. 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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15. 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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16. 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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18. 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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20. Faster Remission of Chronic Depression with Combined Psychotherapy and Medication than with Each Therapy Alone

Author

Manber, Rachel, Kraemer, Helena C., Arnow, Bruce A., Trivedi, Madhukar H., Rush, A. John, Thase, Michael E., Rothbaum, Barbara O., Klein, Daniel N., Kocsis, James H., Gelenberg, Alan J., and Keller, Martin E.

Abstract

The main aim of the present novel reanalysis of archival data was to compare the time to remission during 12 weeks of treatment of chronic depression following antidepressant medication (n = 218), psychotherapy (n = 216), and their combination (n = 222). Cox regression survival analyses revealed that the combination of medication and psychotherapy produced full remission from chronic depression more rapidly than either of the single modality treatments, which did not differ from each other. Receiver operating characteristic curve analysis was used to explore predictors (treatment group, demographic, clinical, and psychosocial) of remission. For those receiving the combination treatment, the most likely to succeed were those with low baseline depression (24-item Hamilton Rating Scale for Depression [HRSD; M. Hamilton, 1967] score less than 26) and those with high depression scores but low anxiety (HRSD greater than or equal to 26 and Hamilton Anxiety Rating Scale [M. Hamilton, 1959] less than 14). Both profiles were associated with at least 40% chance of attaining full remission. The model did not identify predictors for those receiving medication or psychotherapy alone, and it did not distinguish between the 2 monotherapies. The authors conclude that combined antidepressant medications and psychotherapy result in faster full remission of chronic forms of major depressive disorder. (Contains 3 figures and 2 tables.)

Published
2008
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25. Lithium plus antipsychotics or anticonvulsants for bipolar disorder: Comparing clinical response and metabolic changes.

Author

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

Subjects
THERAPEUTIC use of lithium, METABOLIC syndrome risk factors, METABOLIC syndrome diagnosis, ANTICONVULSANTS, DRUG efficacy, BIOMARKERS, LAMOTRIGINE, TRIGLYCERIDES, COMBINATION drug therapy, ANALYSIS of variance, ARIPIPRAZOLE, QUETIAPINE, REGRESSION analysis, BLOOD sugar, COMPARATIVE studies, DESCRIPTIVE statistics, ANTIPSYCHOTIC agents, BIPOLAR disorder, LITHIUM, SECONDARY analysis, VALPROIC acid, EVALUATION
Abstract

Objective: Patients with bipolar disorder treated with lithium often require additional antipsychotics or anticonvulsants. However, the comparative effectiveness and safety of these agents as add-on to lithium has not been studied. Methods: This secondary analysis combined two similar 24-week trials on outpatients with bipolar disorder randomized to lithium (target serum level 0.4–0.6 mEq/L). Guideline-based adjunctive antipsychotics (Li+AP) and anticonvulsants (Li+AC) could be used if clinically indicated and was assessed at every study visit. Response was measured on the Clinical Global Impression scale and we performed adjusted mixed effects linear regression analyses. Analysis of variance tests compared metabolic measures including a binary diagnosis of metabolic syndrome before and after 24 weeks of treatment. Results: Among 379 outpatients (57% female, mean age 38 years, mean Clinical Global Impression 4.4), users of Li+AP (N = 50, primarily quetiapine and aripiprazole) improved to a similar degree (mean Clinical Global Impression improvement = 1.6, standard deviation = 1.5) as those using lithium-only (i.e. without adjunctive antipsychotics or anticonvulsants, N = 149, mean Clinical Global Impression improvement = 1.7, standard deviation = 1.4) (p = 0.59). Users of Li+AC (N = 107, primarily lamotrigine and valproate, mean Clinical Global Impression improvement = 1.2, standard deviation = 1.3) and users of Li+AP+AC (N = 73, mean Clinical Global Impression improvement = 1.1, standard deviation = 1.3) showed worse response compared to lithium-only users (all p < 0.01). When comparing Li+AP to Li+AC, users of Li+AP improved slightly better on general (p = 0.05) and manic symptoms (p = 0.01), but showed a worse development of glucose, triglycerides, and metabolic syndrome. Conclusion: Despite treatment-by-indication confounding, these findings are relevant for real-world treatment settings and emphasize the need for randomized trials on this clinically important topic. [ABSTRACT FROM AUTHOR]

Published
2023
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28. Medical burden in bipolar disorder: findings from the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder study (Bipolar CHOICE)

Author

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

Published
2015
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31. Cognitive behavioral analysis system of psychotherapy and brief supportive psychotherapy for augmentation of antidepressant nonresponse in chronic depression: the REVAMP trial

Author

Kocsis, James H., Gelenberg, Alan J., Rothbaum, Barbara O., Klein, Daniel N., Trivedi, Madhukar H., Manber, Rachel, Keller, Martin B., Leon, Andrew C., Wisniewski, Steven R., Arnow, Bruce A., Markowtiz, John C., and Thase, Michael E.

Subjects
Immune response -- Research, Major depressive disorder -- Care and treatment, Major depressive disorder -- Patient outcomes, Major depressive disorder -- Research, Psychotherapy -- Patient outcomes, Psychotherapy -- Research, Antidepressants -- Dosage and administration, Antidepressants -- Research, Health, Psychology and mental health
Published
2009

32. Childhood trauma and treatment outcomes during mood‐stabilising treatment with lithium or quetiapine among outpatients with bipolar disorder.

Author

Wrobel, Anna L., Köhler‐Forsberg, Ole, Sylvia, Louisa G., Russell, Samantha E., Dean, Olivia M., Cotton, Sue M., Thase, Michael, Calabrese, Joseph R., Deckersbach, Thilo, Tohen, Mauricio, Bowden, Charles L., McInnis, Melvin G., Kocsis, James H., Friedman, Edward S., Ketter, Terence A., Shelton, Richard C., Ostacher, Michael J., Iosifescu, Dan V., Berk, Michael, and Turner, Alyna

Subjects
ADVERSE childhood experiences, BIPOLAR disorder, THERAPEUTIC use of lithium, TREATMENT effectiveness, AFFECTIVE disorders
Abstract

Background: Childhood trauma affects the course of mood disorders. Researchers are now considering childhood trauma as an influential factor in the treatment of mood disorders. However, the role of childhood trauma in the treatment of bipolar disorder remains understudied. Methods: The effect of childhood trauma on treatment outcomes was evaluated among participants randomised to treatment with lithium or quetiapine in the Clinical and Health Outcomes Initiatives in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE) study by clinician assessment. Mixed effects linear regression models were used to analyse rates of improvement in symptom severity (assessed with the Bipolar Inventory of Symptoms Scale and the Clinical Global Impression Scale for Bipolar Disorder) and functional impairment (assessed with the Longitudinal Interval Follow‐up Evaluation‐Range of Impaired Functioning Tool). Results: A history of any childhood trauma was reported by 52.7% of the sample (N = 476). Although participants with a history of any childhood trauma presented with greater symptom severity and functional impairment at most study visits, participants with and without a history of any childhood trauma showed similar rates of improvement in symptom severity and functional impairment over the 24 weeks of treatment. Conclusion: This is the first study to explore the association between childhood trauma and treatment outcomes during treatment with lithium or quetiapine in the context of a randomised trial. In Bipolar CHOICE, a history of childhood trauma did not inhibit improvement in symptom severity or functional impairment. Nevertheless, these findings need replication across different settings. [ABSTRACT FROM AUTHOR]

Published
2022
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33. Familial severe psychiatric history in bipolar disorder and correlation with disease severity, treatment response and type of bipolar

Author

Köhler-Forsberg, Ole, Sylvia, Louisa, Ruberto, Valerie, Kuperberg, Maya, Shannon, Alec, 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, Iosifescu, Dan V, McElroy, Susan, Ostacher, Michael J, and A. Nierenberg, Andrew

Published
2020

35. Cognitive-behavioral analysis system of psychotherapy as a maintenance treatment for chronic depression

Author

Klein, Daniel N., Santiago, Neil J., Vivian, Dina, Blalock, Janice A., Kocsis, James H., Markowitz, John C., McCullough, James P., Jr., Rush, A. John, Trivedi, Madhukar H., Borian, Frances E., Arnow, Bruce A., Dunner, David L., Manber, Rachel, Rothbaum, Barbara, Thase, Michael E., Keitner, Gabor I., Miller, Ivan W., and Keller, Martin B.

Subjects
Depression, Mental -- Care and treatment, Depression, Mental -- Research, Psychology and mental health
Abstract

Although the efficacy of maintenance pharmacotherapy for the prevention of recurrence in major depressive disorder (MDD) is well documented, few studies have tested the efficacy of psychotherapy as a maintenance treatment. The authors examined the efficacy of the cognitive-behavioral analysis system of psychotherapy (CBASP) as a maintenance treatment for chronic forms of MDD. Eighty-two patients who had responded to acute and continuation phase CBASP were randomized to monthly CBASP or assessment only for 1 year. Significantly fewer patients in the CBASP than assessment only condition experienced a recurrence. The 2 conditions also differed significantly on change in depressive symptoms over time. These findings support the use of CBASP as a maintenance treatment for chronic forms of MDD.

Published
2004

38. Commentary

Author

Kocsis, James H

Published
2013

39. Pharmacotheraphy for chronic depression

Author

Kocsis, James H.

Subjects
Depression, Mental -- Drug therapy, Antidepressants -- Health aspects, Psychology and mental health
Abstract

This article reviews the current status of the treatment of chronic depression with antidepressant medications. Short and longer term clinical trials that have investigated the efficacy of several classes of antidepressants are summarized. The important outcomes of treatment in these studies, including response category, symptom reduction, and improved psychosocial function, are elaborated. Short-term trials seem reasonably conclusive in establishing the effectiveness of antidepressants for dysthymia and double depression, although rates of remission fall short of 50%. Keywords: chronic depression; antidepressants; pharmacotherapy

Published
2003

45. The Neglected Role of Psychotherapy for Treatment-Resistant Depression.

Author

Markowitz, John C., Wright, Jesse H., Peeters, Frenk, Thase, Michael E., Kocsis, James H., and Sudak, Donna M.

Subjects
PSYCHOTHERAPY, COGNITIVE therapy, PSYCHOTIC depression, MENTAL depression, CAREGIVERS, EVIDENCE-based psychotherapy
Abstract

The article presents the discussion on the concept of treatment-resistant or treatment refractory depression (TRD). Topics include recognizing and test painful, distorted negative thinking like cognitive therapy or understanding and using emotions in solving interpersonal difficulties; and psychotherapy tempering the inherent depressive hopelessness and demoralization repeating medication non response reinforces.

Published
2022
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