Reimherr F W, Amsterdam J D, Quitkin F M, Rosenbaum J F, Fava M, Zajecka J, Beasley C M, Michelson D, Roback P, Sundell K
Department of Psychiatry, University of Utah, Salt Lake City, USA.
Am J Psychiatry. 1998 Sep;155(9):1247-53. doi: 10.1176/ajp.155.9.1247.
The purpose of this study was to determine prospectively the optimal length of therapy in a long-term, placebo-controlled continuation study of patients who responded to acute fluoxetine treatment for major depression (defined by DSM-III-R).
The study was conducted at five outpatient psychiatric clinics in the United States. Patients who met criteria for remission after 12 or 14 weeks of open-label acute fluoxetine therapy, 20 mg/day (N=395 of 839 patients), were randomly assigned to one of four arms of a double-blind treatment study (50 weeks of placebo, 14 weeks of fluoxetine and then 36 weeks of placebo, 38 weeks of fluoxetine and then 12 weeks of placebo, or 50 weeks of fluoxetine). Relapse rate was the primary outcome measure. Both Kaplan-Meier estimates and observed relapse rates were assessed in three fixed 12-week intervals after double-blind transfers from fluoxetine to placebo at the start of the double-blind period and after 14 and 38 weeks of continued fluoxetine treatment.
Relapse rates (Kaplan-Meier estimates) were lower among the patients who continued to take fluoxetine compared with those transferred to placebo in both the first interval, after 24 total weeks of treatment (fluoxetine, 26.4%; placebo, 48.6%), and the second interval, after 38 total weeks of treatment (fluoxetine, 9.0%; placebo, 23.2%). In the third interval, after 62 total weeks of treatment, rates were not significantly different between the groups (fluoxetine, 10.7%; placebo, 16.2%).
Patients treated with fluoxetine for 12 weeks whose depressive symptoms remit should continue treatment with fluoxetine for at least an additional 26 weeks to minimize the risk of relapse.
本研究的目的是在一项针对因重度抑郁症（由《精神疾病诊断与统计手册第三版修订本》定义）接受急性氟西汀治疗有反应的患者的长期、安慰剂对照延续性研究中，前瞻性地确定最佳治疗时长。
该研究在美国的五家门诊精神科诊所进行。在接受为期12周或14周、每日20毫克的开放标签急性氟西汀治疗后达到缓解标准的患者（839名患者中的395名），被随机分配至双盲治疗研究的四个组之一（50周安慰剂、14周氟西汀然后36周安慰剂、38周氟西汀然后12周安慰剂，或50周氟西汀）。复发率是主要结局指标。在双盲期开始时从氟西汀转为安慰剂后以及继续进行14周和38周氟西汀治疗后的三个固定12周间隔内，评估了Kaplan-Meier估计值和观察到的复发率。
在治疗总周数达24周后的第一个间隔期（氟西汀组，26.4%；安慰剂组，48.6%）以及治疗总周数达38周后的第二个间隔期（氟西汀组，9.0%；安慰剂组，23.2%），继续服用氟西汀的患者复发率（Kaplan-Meier估计值）低于转为安慰剂的患者。在治疗总周数达62周后的第三个间隔期，两组复发率无显著差异（氟西汀组，10.7%；安慰剂组，16.2%）。
接受氟西汀治疗12周且抑郁症状缓解的患者，应继续使用氟西汀治疗至少额外26周，以将复发风险降至最低。
