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首页> 外文期刊>The journal of clinical psychiatry >Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study).
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Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study).

机译：继续使用喹硫平与转用安慰剂或锂进行维持治疗双相性I型障碍（试验144：一项随机对照研究）。

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OBJECTIVE: Quetiapine, combined with lithium or divalproex, demonstrates efficacy in the maintenance treatment of bipolar I disorder. This study investigated the efficacy and safety of quetiapine monotherapy as maintenance treatment in bipolar I disorder compared with switching to placebo or lithium. METHOD: Patients aged >/= 18 years with DSM-IV-diagnosed bipolar I disorder and a current or recent manic, depressive, or mixed episode received open-label quetiapine (300-800 mg/d) for 4-24 weeks. Patients achieving stabilization were randomized to continue quetiapine or to switch to placebo or lithium (0.6-1.2 mEq/L) for up to 104 weeks in a double-blind trial. Outcome measures included times to recurrence of any mood event (primary outcome measure), manic event, or depressive event. Safety assessments included adverse events and laboratory values. The study was terminated early after planned interim analysis provided positive results. The study was conducted between March 2005 and July 2007. RESULTS: Of 2,438 patients starting open-label quetiapine, 1,226 (50.3%) were randomized to double-blind treatment, including 1,172 (95.6%) in the intent-to-treat population. Time to recurrence of any mood event was significantly longer for quetiapine versus placebo (hazard ratio [HR] = 0.29; 95% CI, 0.23-0.38; P < .0001) and for lithium versus placebo (HR = 0.46; 95% CI, 0.36-0.59; P < .0001). Quetiapine and lithium significantly increased time to recurrence of both manic events (quetiapine: HR = 0.29; 95% CI, 0.21-0.40; P < .0001; lithium: HR = 0.37; 95% CI, 0.27-0.53; P < .0001) and depressive events (quetiapine: HR = 0.30; 95% CI, 0.20-0.44; P < .0001; lithium: HR = 0.59; 95% CI, 0.42-0.84; P < .004) compared with placebo. Overall rates of adverse events were generally similar between treatment groups, and safety findings for quetiapine were consistent with its known profile. CONCLUSIONS: In patients stabilized during acute quetiapine treatment, continuation of quetiapine significantly increased time to recurrence of any mood, manic, or depressive event compared with switching to placebo. Switching to lithium was also more effective than placebo for the prevention of manic and depressive events. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00314184.
机译：目的：喹硫平与锂或双丙戊酸钠合用，在维持双相性I型障碍的治疗中显示出疗效。这项研究调查了喹硫平单药作为维持性治疗双相性I型障碍与转用安慰剂或锂相比的疗效和安全性。方法：年龄> / = 18岁，患有DSM-IV诊断的双相I型障碍且当前或最近出现躁狂，抑郁或混合发作的患者接受开放标签的喹硫平（300-800 mg / d），治疗4-24周。在双盲试验中，将达到稳定的患者随机分组以继续使用喹硫平或改用安慰剂或锂（0.6-1.2 mEq / L）长达104周。结果指标包括任何情绪事件（主要结果指标），躁狂事件或抑郁事件复发的时间。安全评估包括不良事件和实验室值。在计划中的中期分析提供了积极的结果之后，研究被提早终止。该研究于2005年3月至2007年7月进行。结果：在开始使用开放标签喹硫平的2438例患者中，有1226例（50.3％）被随机分配为双盲治疗，其中意向性治疗人群中有1,172例（95.6％）。喹硫平与安慰剂相比，任何情绪事件的复发时间明显更长（危险比[HR] = 0.29; 95％CI，0.23-0.38; P <.0001）;锂与安慰剂相比（HR = 0.46; 95％CI， 0.36-0.59; P <.0001）。喹硫平和锂显着增加了两种躁狂事件复发的时间（喹硫平：HR = 0.29; 95％CI，0.21-0.40; P <.0001;锂：HR = 0.37; 95％CI，0.27-0.53; P <.0001 ）和抑郁事件（喹硫平：HR = 0.30; 95％CI，0.20-0.44; P <.0001;锂：HR = 0.59; 95％CI，0.42-0.84; P <.004）。治疗组之间的总体不良事件发生率基本相似，喹硫平的安全性研究结果与其已知特征相符。结论：在急性喹硫平治疗期间稳定的患者中，与改用安慰剂相比，喹硫平的持续使用显着增加了任何情绪，躁狂或抑郁事件复发的时间。在预防躁狂和抑郁事件方面，改用锂也比安慰剂更有效。试验注册：clinicaltrials.gov标识符：NCT00314184。

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