CHILDHOOD DEPRESSION: REMISSION AND RELAPSE

描述(摘自申请者摘要)：重度抑郁障碍 儿童和青少年(MDD)是一种严重的精神障碍，导致 相当高的发病率和死亡率。直到最近，缺乏明确的经验证据 有证据表明，对急性治疗有效的药物治疗 与继续治疗疗效无关的研究。已完成 氟西汀治疗MDD的双盲安慰剂对照试验 旨在将我们在精神药物治疗MDD方面的工作扩展到 儿童和青少年，通过研究a)延续的有效性 医疗；b)以下社会学校、家庭和认知结果 急性治疗和继续治疗；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；急性 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) MDD经过两周的诊断评估后，将使用氟西汀进行治疗 (10-40 mg)，连续12周。急救人员(n=120)将是 随机服用安慰剂或继续服用相同剂量的氟西汀，并将 随后又进行了24周的观察。主要结果变量将是 对急性治疗的反应和持续治疗期间复发。 目前还没有关于抑郁症是否需要继续治疗的研究 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.