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首页> 外文期刊>The journal of clinical psychiatry >A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram
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A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram

机译：艾司西酞普兰治疗后伴有重度抑郁症残留症状的成人使用赖氨地西敏二甲磺酸酯作为增强疗法的有效性和安全性的随机对照试验

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Objective: Evaluate the efficacy and safety of lisdexamfetamine dimesylate augmentation for major depressive disorder (MDD) in escitalopram nonremitters. Method: In this proof-of-concept study (conducted from July 2009-August 2010) with a prespecified critical α = .10, adults with nonpsychotic MDD (DSM-IV-TR criteria) and residual depressive symptoms (17-item Hamilton Depression Rating Scale score ≥ 4) after 8 weeks of open-label escitalopram were randomized to 6 weeks of lisdexamfetamine dimesylate (20-50 mg/d) or placebo augmentation. The primary endpoint, Montgomery-Asberg Depression Rating Scale (MADRS) total score change in escitalopram nonremitters (MADRS total score > 10) from week 8 (augmentation baseline) to week 14/end of study, was assessed using analysis of covariance, with last observation carried forward. Results: For nonremitters (placebo, n = 64; lisdexamfetamine dimesylate, n = 65), the least squares (LS) mean (90% CI) treatment difference for MADRS total score reduction at week 14/end of study (-2.3 [-4.5 to -0.1]; P = .0902) met the prespecified criterion for lisdexamfetamine dimesylate superiority (adjusted effect size, -0.3); the number needed to treat for MADRS remission (MADRS total score ≤ 10) was 6.7. The LS mean treatment difference in remitters was not statistically significant (1.2 [-1.6 to 4.0]; P = .4726). Among randomized participants, 49.4% (42/85) receiving placebo and 60.2% (53/88) receiving lisdexamfetamine dimesylate had ≥ 1 treatment-emergent adverse event, the most frequent with lisdexamfetamine dimesylate being dry mouth and headache (both 11.4%). Mean (SD) vital sign and electrocardiogram changes (placebo vs lisdexamfetamine dimesylate) were 0.5 (8.98) versus 2.3 (9.04) mm Hg (systolic blood pressure), -1.0 (7.19) versus 0.9 (6.61) mm Hg (diastolic blood pressure), -0.4 (7.39) versus 4.8 (8.64) beats per minute (heart rate), and -1.6 (11.23) versus -4.9 (11.84) milliseconds (Fridericia-adjusted QTc). Conclusions: Lisdexamfetamine dimesylate augmentation reduced depressive symptoms in participants with inadequate escitalopram response.
机译：目的：评估赖氨苯丙胺二甲磺酸酯增强剂对依他普仑非缓解者的主要抑郁症（MDD）的疗效和安全性。方法：在这项概念验证研究（于2009年7月至2010年8月进行）中，预先确定的临界α= 0.1，患有非精神病性MDD（DSM-IV-TR标准）且有抑郁症残留症状（汉密尔顿抑郁症为17个项目）的成年人在开放标签的艾司西酞普兰8周后，将评定量表评分≥4）随机分配给6周的赖氨苯丙胺二甲磺酸酯（20-50 mg / d）或安慰剂增强。使用协方差分析评估了从第8周（增强基线）到研究第14周/研究结束时，依他普仑非缓解者的Montgomery-Asberg抑郁量表（MADRS）总得分变化（MADRS总得分> 10）。观察发扬光大。结果：对于非缓解者（安慰剂，n = 64;赖氨苯丙胺二甲磺酸盐，n = 65），在第14周/研究结束时MADRS总评分降低的最小二乘（LS）均值（90％CI）治疗差异（-2.3 [- 4.5至-0.1]; P = .0902）达到了赖氨苯丙胺二甲磺酸盐优越性的预先确定的标准（调整后的效应值-0.3）; MADRS缓解所需的治疗数（MADRS总分≤10）为6.7。汇款者的LS平均治疗差异无统计学意义（1.2 [-1.6至4.0]; P = 0.4726）。在随机参与者中，接受安慰剂的49.4％（42/85）和接受赖氨苯丙胺二甲磺酸酯治疗的患者中有60.2％（53/88）出现≥1的治疗不良事件，最常见的赖氨苯丙胺二甲磺酸酯是口干和头痛（均为11.4％）。平均（SD）生命体征和心电图变化（安慰剂vs赖氨苯丙胺二甲磺酸酯）分别为0.5（8.98）vs 2.3（9.04）mm Hg（收缩压），-1.0（7.19）vs 0.9（6.61）mm Hg（舒张压） ，每分钟（心率）-0.4（7.39）对4.8（8.64）节拍，以及-1.6（11.23）对-4.9（11.84）毫秒（经Fridericia调整的QTc）。结论：葡糖胺加二甲磺酸酯减少了依西酞普兰反应不充分的参与者的抑郁症状。

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