Moscovitch Adam, Blashko Carl A, Eagles John M, Darcourt Guy, Thompson Christopher, Kasper Siegfried, Lane Roger M
Canadian Sleep Institute, Unit 300, 295 Midpark Way, South East, Calgary, Alberta, T2X 2A8, Canada.
Psychopharmacology (Berl). 2004 Feb;171(4):390-7. doi: 10.1007/s00213-003-1594-8. Epub 2003 Sep 19.
Seasonal affective disorder (SAD) is a relatively common cyclical depressive illness characterized by seasonal depressions during winter. The disorder is commonly responsive to light therapy, but antidepressant drug efficacy has not been definitely established. Serotonin selective re-uptake inhibitors are potentially efficacious treatments for SAD.
The objective of this study was to evaluate the efficacy, tolerability and safety of sertraline treatment for SAD.
One hundred and eighty seven outpatients with seasonal pattern recurrent winter depression (DSM-III-R defined) and a minimum 29-item Hamilton depression scale (SIGH-SAD version) score of 22 were randomized to 8 weeks treatment with either sertraline or placebo in a double-blind, multi-country, multi-center, parallel-group, flexible dose (50-200 mg once daily) study. Efficacy was investigated using physician and patient-rated scales measuring depression, anxiety and symptoms characteristic of seasonal affective disorder.
Sertraline produced a significantly greater response than placebo at endpoint as measured by changes in the 29-item and 21-item Hamilton depression scales, the clinical global impression (CGI) severity scale, the Hamilton anxiety scale, and the hospital anxiety and depression scale. The proportion of sertraline-treated subjects achieving a response on the CGI improvement rating (ratings of 1 or 2) at endpoint (last observation carried forward) was significantly greater than that of the placebo group. Overall sertraline was well tolerated with the most frequent placebo adjusted adverse events, being nausea, diarrhea, insomnia and dry mouth. Adverse events were mostly mild to moderate and transient.
Sertraline pharmacotherapy has been demonstrated to be an effective and well-tolerated therapy for out patients with SAD. As such, sertraline offers an important pharmacological option in the clinical management of this condition.
季节性情感障碍（SAD）是一种相对常见的周期性抑郁疾病，其特征为冬季出现季节性抑郁。该疾病通常对光照疗法有反应，但抗抑郁药物的疗效尚未明确确立。5-羟色胺选择性再摄取抑制剂可能是治疗SAD的有效方法。
本研究的目的是评估舍曲林治疗SAD的疗效、耐受性和安全性。
187例有季节性复发性冬季抑郁（根据DSM-III-R定义）且汉密尔顿抑郁量表（SIGH-SAD版）最低29项评分达22分的门诊患者，在一项双盲、多国、多中心、平行组、灵活剂量（每日一次50-200mg）研究中，随机接受舍曲林或安慰剂治疗8周。使用医生和患者评定量表来调查疗效，这些量表用于测量抑郁、焦虑以及季节性情感障碍的特征性症状。
根据29项和21项汉密尔顿抑郁量表、临床总体印象（CGI）严重程度量表、汉密尔顿焦虑量表以及医院焦虑抑郁量表的变化测量，在研究终点时舍曲林产生的反应显著大于安慰剂。在终点时（末次观察结转），在CGI改善评定（评定为1或2）上获得反应的舍曲林治疗受试者比例显著高于安慰剂组。总体而言，舍曲林耐受性良好，最常见的经安慰剂调整后的不良事件为恶心、腹泻、失眠和口干。不良事件大多为轻至中度且为短暂性。
舍曲林药物治疗已被证明是治疗SAD门诊患者的一种有效且耐受性良好的疗法。因此，舍曲林为该疾病的临床管理提供了一种重要的药理学选择。
