Greist J H, Jefferson J W, Kobak K A, Chouinard G, DuBoff E, Halaris A, Kim S W, Koran L, Liebowtiz M R, Lydiard B
Dean Foundation for Health, Research and Education, Madison, WI 53717, USA.
Int Clin Psychopharmacol. 1995 Jun;10(2):57-65. doi: 10.1097/00004850-199506000-00001.
The objective of this study was to evaluate the safety and efficacy, over a 1 year treatment period, of three dose levels of sertraline and placebo in the treatment of non-depressed adult out-patients with obsessive-compulsive disorder (OCD). Following 1 week of single-blind placebo washout, patients (n = 325) from 11 sites following identical protocols were randomly assigned to 12 weeks of double-blind treatment with one of three fixed doses of sertraline (50, 100 or 200 mg) or placebo. At the end of 12 weeks, treatment responders (including placebo patients) were offered an additional 40 weeks of double-blind treatment at their assigned doses. Efficacy measures were the Yale-Brown Obsessive Compulsive Scale, the NIMH Global Obsessive Compulsive Scale, Clinical Global Impressions of Severity of Illness and Global Improvement and the Maudsley Obsessive Compulsive Inventory. Patients in the pooled sertraline group showed greater improvement than placebo-treated patients on all efficacy measures, based on the endpoint analyses. Moreover, pairwise comparisons at endpoint revealed a significant effect on all three investigator-rated scales in patients receiving 50 or 200 mg of sertraline; in the 100 mg group, there was a significant effect on the NIMH Global Obsessive Compulsive Scale only. Patients completing 3 months of sertraline treatment exhibited excellent toleration and sustained improvement during an additional 40 weeks of therapy. Results support the safety, efficacy and tolerability of daily doses of 50-200 mg of sertraline in the long-term treatment of patients with OCD.
本研究的目的是评估在为期1年的治疗期内，三种剂量水平的舍曲林及安慰剂治疗无抑郁症状的成年强迫症（OCD）门诊患者的安全性和有效性。在1周的单盲安慰剂洗脱期后，来自11个地点、遵循相同方案的325名患者被随机分配，接受三种固定剂量（50、100或200毫克）的舍曲林或安慰剂之一进行为期12周的双盲治疗。在12周结束时，治疗有反应者（包括服用安慰剂的患者）被提供额外40周的双盲治疗，剂量为其分配的剂量。疗效指标包括耶鲁-布朗强迫症量表、美国国立精神卫生研究所全球强迫症量表、临床总体印象疾病严重程度和总体改善情况以及莫兹利强迫症量表。根据终点分析，在所有疗效指标上，合并的舍曲林组患者比接受安慰剂治疗的患者改善更大。此外，终点时的两两比较显示，接受50或200毫克舍曲林治疗的患者在所有三个研究者评定量表上均有显著效果；在100毫克组中，仅在美国国立精神卫生研究所全球强迫症量表上有显著效果。完成3个月舍曲林治疗的患者在额外40周的治疗期间表现出良好的耐受性和持续改善。结果支持每日50 - 200毫克舍曲林在OCD患者长期治疗中的安全性、有效性和耐受性。
