Rapaport Mark Hyman, Bose Anjana, Zheng Hongjie
Department of Psychiatry, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
J Clin Psychiatry. 2004 Jan;65(1):44-9. doi: 10.4088/jcp.v65n0107.
Current guidelines for antidepressant use recommend 4 to 6 months of continuation treatment to prevent relapse of depression following symptom resolution. This study evaluates the efficacy and safety of continuation escitalopram treatment.
Outpatients diagnosed with DSM-IV major depressive disorder (male or female, aged 18 to 81 years) who had completed 8 weeks of randomized double-blind treatment with escitalopram, citalopram, or placebo entered an 8-week flexible-dose, open-label phase in which all patients received escitalopram (10-20 mg/day). This study was initiated November 3, 1999, and completed April 5, 2001. Patients who met responder criteria (score of < or = 12 on the Montgomery-Asberg Depression Rating Scale [MADRS]) were randomly assigned in a 2:1 ratio to escitalopram (at the dose each patient was receiving at the end of the open-label phase) or placebo for 36 weeks of double-blind treatment. The primary efficacy variable was time to depression relapse (defined as MADRS score > or = 22 or discontinuation due to an insufficient therapeutic response) from the start of the double-blind treatment phase.
A total of 502 patients received open-label escitalopram treatment and had at least 1 MADRS assessment. A total of 274 evaluable subjects entered the double-blind treatment phase; 93 received placebo and 181 received escitalopram. Time to depression relapse was significantly longer (p =.013) and the cumulative rate of relapse was significantly lower in patients who received escitalopram (26% escitalopram vs. 40% placebo; hazard ratio = 0.56; p =.01). Escitalopram-treated subjects had significantly lower depression ratings than those of placebo-treated patients. Escitalopram continuation treatment was safe and well tolerated. Discontinuation rates due to adverse events were 7% for the placebo group and 4% for the escitalopram-treated group.
Continuation treatment with escitalopram is effective in preventing relapse into an episode of major depressive disorder.
当前抗抑郁药物使用指南推荐进行4至6个月的维持治疗，以防止症状缓解后抑郁症复发。本研究评估了艾司西酞普兰维持治疗的疗效和安全性。
被诊断为DSM-IV重度抑郁症的门诊患者（年龄18至81岁，男女不限），在完成了8周的艾司西酞普兰、西酞普兰或安慰剂随机双盲治疗后，进入为期8周的灵活剂量开放标签阶段，在此阶段所有患者均接受艾司西酞普兰（10 - 20毫克/天）治疗。本研究于1999年11月3日启动，2001年4月5日完成。达到缓解标准（蒙哥马利-艾斯伯格抑郁量表[MADRS]评分≤12分）的患者按2:1的比例随机分配至艾司西酞普兰组（剂量为开放标签阶段结束时每位患者所接受的剂量）或安慰剂组，进行36周的双盲治疗。主要疗效变量为自双盲治疗阶段开始至抑郁症复发的时间（定义为MADRS评分≥22分或因治疗反应不足而停药）。
共有502例患者接受了开放标签的艾司西酞普兰治疗并至少进行了1次MADRS评估。共有274例可评估受试者进入双盲治疗阶段；93例接受安慰剂，181例接受艾司西酞普兰。接受艾司西酞普兰治疗的患者抑郁症复发时间显著更长（p = 0.013），复发累积率显著更低（艾司西酞普兰组为26%，安慰剂组为40%；风险比 = 0.56；p = 0.01）。接受艾司西酞普兰治疗的受试者的抑郁评分显著低于接受安慰剂治疗的患者。艾司西酞普兰维持治疗安全且耐受性良好。安慰剂组因不良事件导致的停药率为7%，艾司西酞普兰治疗组为4%。
艾司西酞普兰维持治疗可有效预防重度抑郁症发作的复发。
