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

作者：Nierenberg Andrew A^*; McElroy Susan L; Friedman Edward S; Ketter Terence A; Shelton Richard C; Decker**ach Thilo; McInnis Melvin G; Bowden Charles L; Tohen Mauricio; Kocsis James H; Calabrese Joseph R; Kinrys Gustavo; Bobo William V; Singh Vivek; Kamali Masoud; Kemp David; Brody Benjamin; Reilly Harrington Noreen A; Sylvia Louisa G; Shesler Leah W; Bernstein Emily E; Schoenfeld David; Rabideau Dustin J; Leon Andrew C; Faraone Stephen; Thase Michael E

来源：Journal of Clinical Psychiatry, 2016, 77(1): 90-99.

DOI：10.4088/JCP.14m09349

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 H disorder (D5M-IV-Trt) were randomized for 6 months to receive lithium (n =240) or quetiapine In =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-El, 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.

• 出版日期2016-1