CHILDHOOD DEPRESSION: REMISSION AND RELAPSE

描述（改编自申请人摘要）：重度抑郁症 (MDD)是一种严重的精神疾病， 发病率和死亡率很高。直到最近， 急性治疗的有效药物治疗的证据已经使得 关于继续治疗有效性的不相关研究。已完成 氟西汀治疗MDD的双盲安慰剂对照试验，本申请 旨在扩展我们在MDD的精神药理学治疗方面的工作， 儿童和青少年，通过研究a）继续 B）社会、学校、家庭和认知结果 急性治疗和持续治疗;以及c）治疗的预测因素 无反应和复发。拟议的研究将包括两个阶段： 开放治疗（12周）和随机安慰剂对照停药（6 月）。200名儿童和青少年门诊患者（8-18岁）， 两周诊断评估后的MDD，将接受氟西汀治疗 （10- 40 mg）12周。急性治疗的应答者（n=120）将 随机分配至安慰剂组或继续使用相同剂量的氟西汀组， 再随访24周。主要结局变量为 对急性治疗的反应和在继续阶段治疗期间的复发。 目前还没有研究表明抑郁症患者需要继续治疗， 儿科年龄组。

DESCRIPTION (Adapted from Applicant's Abstract): Major depressive disorder (MDD) in children and adolescents is a serious psychiatric disorder causing substantial morbidity and mortality. Until recently the lack of clear empirical evidence of effective pharmacological treatment for acute treatment has made irrelevant research on the efficacy of continuation treatment. Having completed a double-blind placebo controlled trial of fluoxetine in MDD, this application aims to extend our work in the psychopharmacological treatment of MDD in children and adolescents, by studying a) the effectiveness of continuation of medical treatment; b) social school, family and cognitive outcomes following acute treatment and continuation treatment; and c) predictors of treatment non-response and relapse. The proposed study will consist of two phases; acute open treatment (12 weeks) and randomized placebo controlled discontinuation (6 months). Two hundred child and adolescent outpatients (ages 8-18 years) with MDD following a two week diagnostic evaluation, will be treated with fluoxetine (10-40mg) for 12 weeks. Responders of acute treatment (n=120) will be randomized to pill placebo or to continue same dose of fluoxetine, and will be followed for an additional 24 weeks. The primary outcome variable will be response to acute treatment and relapse during continuation phase treatment. There have been no studies of need for continuation treatment in depression in the pediatric age group.