Nierenberg Andrew A, McElroy Susan L, Friedman Edward S, Ketter Terence A, Shelton Richard C, Deckersbach 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
Massachusetts General Hospital, 50 Staniford St, Ste 580, Boston, MA 02114
J Clin Psychiatry. 2016 Jan;77(1):90-9. doi: 10.4088/JCP.14m09349.
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.
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.
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).
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.
ClinicalTrials.gov identifier for the Bipolar CHOICE study: NCT01331304.
双相情感障碍是全球最具致残性的10种疾病之一。自20世纪70年代以来，锂盐一直被广泛用于双相情感障碍的治疗，但自1998年起，第二代抗精神病药物（SGA）已取代锂盐。迄今为止，尚无随机对照有效性研究对锂盐和任何一种SGA进行比较。
在研究期间（2010年9月至2013年9月），将符合双相I型或II型障碍（DSM-IV-TR）的参与者随机分为两组，一组接受锂盐治疗（n = 240），另一组接受喹硫平治疗（n = 242），为期6个月。锂盐和喹硫平均与双相情感障碍的其他常规治疗药物联合使用（辅助个性化治疗[APT]，锂盐 + APT组不使用任何SGA，喹硫平 + APT组不使用锂盐或任何其他SGA）。共同主要结局指标包括临床总体印象-疗效指数（CGI-EI）和必要的临床调整，后者通过辅助个性化治疗的变化次数来衡量。次要指标包括一系列症状、心血管风险、功能、生活质量、自杀观念和行为以及不良事件。
所有指标的参与者均有改善，超过20%的参与者有持续缓解。两组间主要结局（CGI-EI，P = 0.59；必要的临床调整，P = 0.15）和次要结局变化无统计学显著差异。对于躁狂/轻躁狂症状较重的参与者，喹硫平 + APT组的CGI-EI变化明显更有利（P = 0.02）。在焦虑症患者中，锂盐 + APT组每月的必要临床调整较少（P = 0.02）。在副作用的频率负担（P = 0.
