High-dose sertraline strategy for nonresponders to acute treatment for obsessive-compulsive disorder: A multicenter double-blind tyial
High-dose sertraline strategy for nonresponders to acute treatment for obsessive-compulsive disorder: A multicenter double-blind tyial
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DOI：
10.4088/jcp.v67n0103
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发表时间：
2006-01-01
影响因子：
5.3
通讯作者：
Austin, C
中科院分区：
文献类型：
--
作者：
Ninan, PT;Koran, LM;Austin, C
目的：评价大剂量舍曲林治疗标准舍曲林急性治疗无效的强迫症（OCD）患者的疗效和安全性。66名对舍曲林治疗16周无反应的患者，符合DSM-III-R当前强迫症的标准，在一项多中心试验的双盲继续阶段被随机分配，或者继续服用200 mg/天舍曲林，或者将剂量增加到250 - 400 mg/天，再服用12周。疗效指标包括耶鲁-布朗强迫量表（YBOCS）、美国国家精神卫生研究所全球强迫量表（NIMH全球OC量表）和临床总体印象-疾病严重程度和改善（CGI-I）量表。数据收集时间为1994年7月26日至1995年10月26日。高剂量根据YBOCS测量，（250-400 mg/天，平均最终剂量= 357，SD = 60，N = 30）组的症状改善显著大于200 mg/天组（N = 36）（p = 0.033），NIMH全球OC量表（p = 0.003）和CGI-I（p = 0.011）。200 mg/d组与高剂量舍曲林组的应答率（YBOCS评分下降>= 25%，CGI-I评分：3）无显著差异，完成者分析为34% vs 52%，终点分析为33% vs 40%。两种治疗方法表现出类似的不良事件rate.Conclusion：更大的症状改善，在高剂量舍曲林组相比，200毫克/天剂量组在继续治疗。两种剂量产生相似的安全性特征。给药高于标示剂量的选择性5-羟色胺再摄取抑制剂可能是某些对标准急性治疗无效的强迫症患者的治疗选择。
Objective: To evaluate the efficacy and safety of high-dose sertraline for patients with obsessive-compulsive disorder (OCD) who failed to respond to standard sertraline acute treatment.Method: Sixty-six nonresponders to 16 weeks of sertraline treatment who met DSM-III-R criteria for current OCD were randomly assigned, in a double-blind continuation phase of a multicenter trial, either to continue on 200 mg/day of sertraline or to increase their dose to between 250 and 400 mg/day for 12 additional weeks. Efficacy measures included the Yale-Brown Obsessive Compulsive Scale (YBOCS), the National Institute of Mental Health Global Obsessive compulsive Scale (NIMH Global OC Scale), and the Clinical Global Impress ions-Severity of Illness and -Improvement (CGI-I) scales. Data were collected from July 26, 1994, to October 26, 1995.Results: The high-dose (250-400 mg/day, mean final dose = 357, SD = 60, N = 30) group showed significantly greater symptom improvement than the 200-mg/day group (N = 36) as measured by the YBOCS (p = .033), NIMH Global OC Scale (p = .003), and CGI-I (p = .011). Responder rates (decrease in YBOCS score of >= 25% and a CGI-I rating: 3) were not significantly different for the 200-mg/day versus the high-dose sertraline group, either on completer analysis, 34% versus 52%, or on endpoint analysis, 33% versus 40%. Both treatments showed similar adverse event rates.Conclusion: Greater symptom improvement was seen in the high-dose sertraline group compared to the 200-mg/day dose group during continuation treatment. Both dosages yielded similar safety profiles. Administration of higher than labeled doses of selective serotonin reuptake inhibitors may be a treatment option for certain OCD patients who fail to respond to standard acute treatment.