Dataset Information

Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder at Any Phase of Illness and at least Mild Symptom Severity.

ABSTRACT:

Objectives

To sequentially study the effectiveness of lithium and divalproex monotherapy and adjunctive therapy with quetiapine or lamotrigine in the acute and continuation treatment of bipolar I or II disorder at any phase of illness and at least mild symptom severity.

Methods

From June 2011 to December 2016, patients with bipolar I or II disorder (using DSM-IV diagnostic criteria) and CGI-S (Clinical Global Impression-Severity) ⩾ 3 were randomized to receive lithium or divalproex monotherapy for 2 weeks. Patients who had CGI-S-depression ⩾ 3 for 2 weeks at any time after 2-week monotherapy were randomly assigned to receive quetiapine or lamotrigine, or remaining on monotherapy for a total of 26 weeks.

Results

The rates of early termination due to lack of efficacy and side effects and changes in BISS (Bipolar Inventory of Symptoms Scale) and CGI-S total score were not significantly different between lithium and divalproex. The completion rate was significantly higher with adjunctive therapy than with monotherapy. BISS and CGI-S total scores, and their sub-scores were significantly reduced with adjunctive therapy compared to monotherapy. Adjunctive therapy significantly increased survival times compared to monotherapy (hazard ratio = 6.8), and the monotherapy group had a significantly increased risk for not reaching sustained recovery from depression (hazard ratio = 12.7). Patients who did not need the 2nd randomization and remained on monotherapy had a significantly reduced hazard for discontinuation (hazard ratio = 3.8).

Conclusions

The efficacy of lithium and divalproex as monotherapy was modest. Adjunctive lamotrigine and quetiapine to either one was well-tolerated and equally effective in reducing bipolar symptomatology, but adjunctive therapy should be initiated as early as possible when depression symptoms are present.

SUBMITTER: Gao K

PROVIDER: S-EPMC7255841 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Publications

Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder at Any Phase of Illness and at least Mild Symptom Severity.

Gao Keming K Arnold Jodi G JG Prihoda Thomas J TJ Quinones Marlon M Singh Vivek V Schinagle Martha M Conroy Carla C D'Arcangelo Nicole N Bai Yuanhan Y Calabrese Joseph R JR Bowden Charles L CL

Psychopharmacology bulletin 20200501 2

<h4>Objectives</h4>To sequentially study the effectiveness of lithium and divalproex monotherapy and adjunctive therapy with quetiapine or lamotrigine in the acute and continuation treatment of bipolar I or II disorder at any phase of illness and at least mild symptom severity.<h4>Methods</h4>From June 2011 to December 2016, patients with bipolar I or II disorder (using DSM-IV diagnostic criteria) and CGI-S (Clinical Global Impression-Severity) ⩾ 3 were randomized to receive lithium or divalproe ...[more]

PMID: 32508363

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Project description:IntroductionThe illness course of bipolar disorder (BD) is highly heterogeneous with substantial variation between individuals with the same BD subtype and within individuals over time. This heterogeneity is not well-delineated and hampers the development of more targeted treatment. Furthermore, although lifestyle-related behaviors are believed to play a role in the illness course, such mechanisms are poorly understood. To address some of these knowledge gaps, we aimed to develop an app for collection of multi-dimensional longitudinal data on BD-relevant symptoms and lifestyle-related behaviors.MethodsAn app named MinDag was developed at the Norwegian Center for Mental Disorders Research in Oslo, Norway. The app was designed to tap into selected areas: mood, sleep, functioning/activities (social, occupational, physical exercise, leisure), substance use, emotional reactivity, and psychotic experiences. Ethical, security and usability issues were highly prioritized throughout the development and for the final app solution. We conducted beta- and pilot testing to eliminate technical problems and enhance usability and acceptability.ResultsThe final version of MinDag comprises six modules; three which are presented for the user once daily (the Sleep module in the morning and the Mood and Functoning/Activities modules in the evening) and three which are presented once weekly (Substance Use, Emotional Reactivity, and Psychotic Experiences modules). In general, MinDag was well received in both in the beta-testing and the pilot study, and the participants provided valuable feedback that was taken into account in the final development. MinDag is now in use as part of the research protocol at the NORMENT center and in a specialized treatment unit for BD at Oslo University Hospital in Norway.DiscussionWe believe that MinDag will generate unique longitudinal data well suited for capturing the heterogeneity of BD and clarifying important unresolved issues such as how life-style related behavior may influence BD symptoms. Also, the experiences and knowledge derived from the development of MinDag may contribute to improving the security, acceptability, and benefit of digital tools in mental health.

Project description:ObjectiveThe Course and Outcome of Bipolar Youth study found that children and adolescents with bipolar spectrum disorders followed 1 of 4 distinct mood trajectories over 8 years of follow-up, with as many as 25% of participants showing a predominantly euthymic course. We evaluated whether similar patterns of illness course are observed in adolescents with bipolar I and II disorder who participated in a 2-year clinical trial.MethodA total of 144 adolescents with bipolar I or II disorder, identified shortly after a mood episode, were assessed over a 2-year period. Participants were randomly assigned to one of 2 psychosocial family treatments during the first 9 months of the study, and pharmacotherapy was provided throughout the 2 years. Using latent class growth analyses, we classified participants into distinct courses of illness based on mood ratings collected over the 2 years. We examined demographic and illness variables as predictors of these course classifications.ResultsLatent class growth analyses indicated four mood trajectories: "predominantly euthymic" (29.9% of sample), "ill with significantly improving course" (11.1%), "moderately euthymic" (26.4%), and "ill with moderately improving course" (32.6%). Adolescents in these classes were euthymic 77.7%, 53.6%, 44.1%, and 18.6% of the weeks of follow-up, respectively. Psychosocial treatment condition and baseline medication exposure were not associated with trajectories. However, youth with more severe baseline depressive symptoms, suicidality, lower quality of life scores, and minority race/ethnicity had more symptomatic courses of illness over time.ConclusionA substantial proportion (25%-30%) of youth with bipolar I or II disorder maintain euthymic states over extended periods of follow-up. Identifying youth who are more and less likely to remain stable over time may help guide psychosocial and pharmacological treatments after an illness episode.Clinical trial registration informationEffectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents; https://clinicaltrials.gov/; NCT00332098.

Dataset Information

Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder at Any Phase of Illness and at least Mild Symptom Severity.

Objectives

Methods

Results

Conclusions

Publications

Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder at Any Phase of Illness and at least Mild Symptom Severity.

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