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Original Research

Bipolar CHOICE (Clinical Health Outcomes Initiative in Comparative Effectiveness): A Pragmatic 6-Month Trial of Lithium Versus Quetiapine for Bipolar Disorder

Andrew A. Nierenberg, MDa,b,*; Susan L. McElroy, MDc; Edward S. Friedman, MDd; Terence A. Ketter, MDe; Richard C. Shelton, MDf; Thilo Deckersbach, PhDa,b; Melvin G. McInnis, MDg; Charles L. Bowden, MDh; Mauricio Tohen, MD, DrPH, MBAi; James H. Kocsis, MDj; Joseph R. Calabrese, MDk; Gustavo Kinrys, MDa,b; William V. Bobo, MDl; Vivek Singh, MDh,† ; Masoud Kamali, MDg; David Kemp, MDk; Benjamin Brody, MDj; Noreen A. Reilly-Harrington, PhDa,b; Louisa G. Sylvia, PhDa,b; Leah W. Shesler, BAa; Emily E. Bernstein, BSa; David Schoenfeld, PhDm; Dustin J. Rabideau, MSm; Andrew C. Leon, PhDj,† ; Stephen Faraone, PhDn; and Michael E. Thase, MDo

Published: January 27, 2016

Article Abstract

Background: Bipolar disorder is among the 10 most disabling medical conditions worldwide. While lithium has been used extensively for bipolar disorder since the 1970s, second-generation antipsychotics (SGAs) have supplanted lithium since 1998. To date, no randomized comparative-effectiveness study has compared lithium and any SGA.

Method: Within the duration of the study (September 2010-September 2013), participants with bipolar I or II disorder (DSM-IV-TR) were randomized for 6 months to receive lithium (n = 240) or quetiapine (n = 242). Lithium and quetiapine were combined with other medications for bipolar disorder consistent with typical clinical practice (adjunctive personalized treatment [APT], excluding any SGA for the lithium + APT group and excluding lithium or any other SGA for the quetiapine + APT group). Coprimary outcome measures included Clinical Global Impressions-Efficacy Index (CGI-EI) and necessary clinical adjustments, which measured number of changes in adjunctive personalized treatment. Secondary measures included a full range of symptoms, cardiovascular risk, functioning, quality of life, suicidal ideation and behavior, and adverse events.

Results: Participants improved across all measures, and over 20% had a sustained response. Primary (CGI-EI, P = .59; necessary clinical adjustments, P = .15) and secondary outcome changes were not statistically significantly different between the 2 groups. For participants with greater manic/hypomanic symptoms, CGI-EI changes were significantly more favorable with quetiapine + APT (P = .02). Among those with anxiety, the lithium + APT group had fewer necessary clinical adjustments per month (P = .02). Lithium was better tolerated than quetiapine in terms of the burden of side effects frequency (P = .05), intensity (P = .01), and impairment (P = .01).

Conclusions: Despite adequate power to detect clinically meaningful differences, we found outcomes with lithium + APT and quetiapine + APT were not significantly different across 6 months of treatment for bipolar disorder.

Trial Registration: identifier for the Bipolar CHOICE study: NCT01331304

Volume: 77

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