Capital Clinical Research Associates, Rockville, MD 20852, USA.
J Clin Psychiatry. 2013 Feb;74(2):158-66. doi: 10.4088/JCP.12m07974.
To evaluate the long-term (11-month) efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) at the recommended 50-mg/d dose in preventing relapse in patients with major depressive disorder (MDD).
Adult outpatients (age ≥ 18 years) with MDD (DSM-IV criteria) and a 17-item Hamilton Depression Rating Scale (HDRS17) total score ≥ 20 at screening and baseline were enrolled in a multicenter, double-blind, placebo-controlled, randomized withdrawal trial conducted between June 2009 and March 2011. Patients who responded to 8-week open-label treatment with desvenlafaxine 50 mg/d with continuing stable response through week 20 were randomly assigned to receive placebo or desvenlafaxine 50 mg/d in a 6-month, double-blind, randomized withdrawal period. The primary efficacy endpoint was time to relapse following randomization to double-blind treatment, which was compared between groups using the log-rank test. Relapse was defined as HDRS17 total score ≥ 16, discontinuation for unsatisfactory response, hospitalization for depression, suicide attempt, or suicide. Safety and tolerability data were collected throughout the trial.
A total of 874 patients were enrolled; 548 patients were randomly assigned to receive placebo (n = 276) or desvenlafaxine 50 mg/d (n = 272) in the double-blind withdrawal period. Time to relapse was significantly shorter for placebo versus desvenlafaxine (P < .001). At the end of the 6-month double-blind treatment, the estimated probability of relapse was 30.2% for placebo versus 14.3% for desvenlafaxine 50 mg/d. Safety and tolerability results were generally consistent with those in short-term studies of desvenlafaxine 50 mg/d.
Desvenlafaxine at the recommended dose of 50 mg/d was effective in relapse prevention of depression during a 6-month period in patients who demonstrated stable response after 20 weeks of open-label desvenlafaxine treatment.
ClinicalTrials.gov identifier: NCT00887224.
评估去甲文拉法辛（以去甲文拉法辛琥珀酸盐的形式给药）在推荐的 50mg/d 剂量下预防复发性抑郁症（MDD）的长期（11 个月）疗效和安全性。
成年门诊患者（年龄≥18 岁）患有 MDD（DSM-IV 标准）和汉密尔顿抑郁评定量表 17 项总分（HDRS17）≥20 分，在筛选和基线时入组，进行一项多中心、双盲、安慰剂对照、随机撤药试验，于 2009 年 6 月至 2011 年 3 月进行。对接受 8 周去甲文拉法辛 50mg/d 开放标签治疗并持续稳定应答至第 20 周的患者，随机分配接受安慰剂或去甲文拉法辛 50mg/d 治疗 6 个月的双盲撤药期。主要疗效终点是随机分组后至复发的时间，采用对数秩检验比较组间差异。复发定义为 HDRS17 总分≥16、因不满意的应答而停药、因抑郁住院、自杀企图或自杀。在整个试验过程中收集安全性和耐受性数据。
共纳入 874 例患者；548 例患者被随机分配至双盲撤药期接受安慰剂（n=276）或去甲文拉法辛 50mg/d（n=272）治疗。安慰剂组的复发时间明显短于去甲文拉法辛组（P＜0.001）。在 6 个月双盲治疗结束时，安慰剂组的估计复发率为 30.2%，去甲文拉法辛 50mg/d 组为 14.3%。安全性和耐受性结果与短期去甲文拉法辛 50mg/d 研究结果基本一致。
在接受 20 周开放标签去甲文拉法辛治疗后稳定应答的患者中，去甲文拉法辛推荐剂量 50mg/d 可有效预防抑郁症 6 个月内的复发。
ClinicalTrials.gov 标识符：NCT00887224。
