Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Childhood Depression

描述（由申请人提供）：儿童期发作的单极抑郁症会影响学校表现、社会交往和家庭关系，并且通常是慢性、严重、发作性抑郁症的开始，持续到青春期和成年期（Birmaher等，2007）。患有单相抑郁症的儿童出现突发自杀意念/行为、药物滥用、法律问题、身体疾病和早孕的风险更高（Birmaher等）。大约2%至4%的儿童患有重度抑郁症或心境恶劣障碍，5%至10%的儿童和青少年患有亚综合征性抑郁症状（Birmaher等人）。由于其普遍性和与当前和未来显著功能缺陷的关联，儿童抑郁症值得治疗研究。治疗方法包括药理学和心理治疗干预，尽管这两种方法对12岁及以下儿童都有很大的局限性。最近的一项荟萃分析发现，氟西汀是唯一一种具有显著经验支持的抗抑郁药物，可以减少儿童抑郁症，但由于担心治疗会产生自杀意念/行为，美国食品和药物管理局（Food and Drug Administration）要求在该年龄组使用抗抑郁药物时发出黑框警告（Bridge等人，2007年）。关于抗抑郁药使用对发育影响的纵向数据尚无。这些担忧引发了人们对替代疗法的兴趣，包括膳食补充剂，特别是omega-3脂肪酸。？治疗情绪障碍的研究3是有希望的（Schacter et al, 2005）；然而，仅有一项儿童随机对照试验结果为阳性（Nemets et al, 2006）。其他临床人群（ADHD、青少年抑郁、焦虑和儿童广泛性发育障碍）的研究结果表明，联合治疗是有利的（Aman等，2009；MTA合作小组，1999a,b, 2004a,b； TADS小组，2007；Walkup等，2008）。然而，令人惊讶的是，人们对12岁及以下临床抑郁症儿童的心理治疗效果知之甚少。认知行为疗法（CBT）的随机对照试验（rct）是通过学校为基础的项目对有情绪升高症状的儿童进行的，而不是对诊断为抑郁症的临床转诊儿童进行的。一些研究人员开始开发和测试基于手册的个人/家庭治疗方法，用于临床转诊的抑郁症儿童（Kovacs等人，2006；thompson等人，2007）；然而，尚未完成随机对照试验。现有研究支持结合抑郁心理教育、支持和技能建设来减少抑郁症状（Birmaher等）。我们之前开发并测试了针对8-12岁情绪障碍儿童的心理教育心理疗法（PEP）。目前的研究比较了？在一项为期12周的试验中，60名患有单相抑郁症的儿童接受了3、PEP和安慰剂补充和主动监测（AM）的联合治疗。在参加为期12周的试验前一个月，参与者不得参加研究外的抑郁症治疗。主要目标是确定：1)可行性a)在24个月内招募60名参与者；B)在12周的试验中保留参与者；2)效应值？3、PEP、联合治疗。次要目标是探索随时间变化的反应曲线、介质和调节因子、一系列结果变量的治疗反应、治疗依从性和副作用。这个试点研究？PEP和联合治疗将为更大规模的试验是否可行和合理提供证据。

DESCRIPTION (provided by applicant): Childhood-onset unipolar depression impacts school performance, social interactions, and family relationships and is often the beginning of chronic, severe, episodic depression persisting into adolescence and adulthood (Birmaher et al, 2007). Children with unipolar depression are at higher risk for emergent suicidal ideation/behavior, substance abuse, legal problems, physical illness, and early pregnancy (Birmaher et al). Approximately 2 to 4% of children experience either major depressive disorder or dysthymic disorder and 5 to 10% of children and adolescents experience subsyndromal depressive symptoms (Birmaher et al). Due to its prevalence and association with significant current and future functioning deficits, childhood depression warrants treatment research. Treatments include pharmacological and psychotherapeutic interventions, although both have significant limitations in children age 12 and under. A recent meta-analysis found fluoxetine to be the only antidepressant medication with significant empirical support for decreasing depression in children, but concerns about treatment-emergent suicidal ideation/behavior led the Food and Drug Administration to mandate black-box warning for use of antidepressants in this age group (Bridge et al, 2007). Longitudinal data about the developmental impact of antidepressant use are not available. These worries have prompted interest in alternative therapies including dietary supplements, in particular, omega-3 fatty acids (?3). Research on treatment of mood disorders with ?3 is promising (Schacter et al, 2005); however, only one RCT has been conducted in children, which was positive (Nemets et al, 2006). Findings from other clinical populations (ADHD, adolescent depression, anxiety and pervasive developmental disorders in children) suggest combination treatments are advantageous (Aman et al., 2009; The MTA Cooperative Group, 1999a,b, 2004a,b; The TADS Team, 2007; Walkup et al., 2008). However, surprisingly little is known about the effectiveness of psychotherapy for children age 12 and under who are clinically depressed. Randomized controlled trials (RCTs) of cognitive-behavioral therapy (CBT) have been conducted via school- based programs for children with elevated mood symptoms rather than for clinic-referred children diagnosed with a depressive disorder. Several researchers are beginning to develop and test manual-based individual/family therapies for clinic-referred children with diagnosable depression (Kovacs et al, 2006; Tompson et al, 2007); however, no RCTs have been completed. Existing research supports incorporating psychoeducation about depression, support, and skill building to decrease depressive symptoms (Birmaher et al). We previously developed and tested psychoeducational psychotherapy (PEP) for children aged 8-12 with mood disorders. The current study compares ?3, PEP, and their combination to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with unipolar depression. Participants may not participate in treatment for depression outside the study from one month prior to participation throughout the 12-week trial. Primary goals are to determine: 1) feasibility of a) recruiting 60 participants in 24 months; b) retaining participants over a 12-week trial; and 2) effect sizes for ?3, PEP, and combination treatment. Secondary goals are to explore response curves over time, mediators and moderators, treatment response across a broad array of outcome variables, adherence to treatment, and side effects. This pilot study of ?3, PEP, and combined treatment will provide evidence about whether a larger trial is feasible and justifiable.