Rynn Moira, Wagner Karen Dineen, Donnelly Craig, Ambrosini Paul, Wohlberg Christopher J, Landau Phyllis, Yang Ruoyong
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA.
J Child Adolesc Psychopharmacol. 2006 Feb-Apr;16(1-2):103-16. doi: 10.1089/cap.2006.16.103.
The aim of this study was to assess the long-term safety, tolerability, and efficacy of sertraline 50-200 mg once-daily in children (6-11 year olds) and adolescents (12-18 year olds) with a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of major depressive disorder (MDD).
This study consisted of a 24-week open-label observational study of children and adolescents who had completed either of two 10-week double-blind, placebo-controlled trials. The Children's Depression Rating Scale-Revised (CDRS-R) was the primary measure of efficacy.
Two hundred ninety nine (299) patients completed the acute studies and were eligible for the extension study. Of these, 226 enrolled, but 5 did not receive treatment. Of 221 patients (107 children and 114 adolescents), 62.4% completed the study. The endpoint mean daily dose was 109.9 mg/day. The mean decrease in CDRS-R score from double-blind baseline was 34.8 points (p < 0.001), with patients showing continued improvement in CDRS-R scores regardless of which treatment they received in the double-blind studies. At endpoint, 86% of patients met CDRS-R responder and 58% CDRS-R remitter criteria.
Sertraline appears to be well tolerated and safe over 24 weeks of treatment in children and adolescents with MDD. Children and adolescents treated with sertraline appear to have increased improvement over that seen in the first 10 weeks of treatment. These findings need confirmation in placebo-controlled studies.
本研究旨在评估每日一次服用50 - 200毫克舍曲林对患有《精神疾病诊断与统计手册》第四版（DSM - IV）诊断的重度抑郁症（MDD）的儿童（6 - 11岁）和青少年（12 - 18岁）的长期安全性、耐受性和疗效。
本研究包括一项为期24周的开放标签观察性研究，研究对象为完成两项10周双盲、安慰剂对照试验中任意一项的儿童和青少年。儿童抑郁评定量表修订版（CDRS - R）是疗效的主要衡量指标。
299名患者完成了急性研究并符合扩展研究的条件。其中，226名患者登记入组，但5名未接受治疗。在221名患者（107名儿童和114名青少年）中，62.4%完成了研究。终点时的平均每日剂量为109.9毫克/天。CDRS - R评分从双盲基线的平均降低值为34.8分（p < 0.001），无论患者在双盲研究中接受何种治疗，其CDRS - R评分均持续改善。在终点时，86%的患者达到CDRS - R反应者标准，58%达到CDRS - R缓解者标准。
舍曲林在治疗患有MDD的儿童和青少年24周期间似乎耐受性良好且安全。接受舍曲林治疗的儿童和青少年在治疗的前10周后似乎有更大的改善。这些发现需要在安慰剂对照研究中得到证实。
