Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Childhood Depression

描述（由申请人提供）：儿童期发作的单相抑郁症影响学校表现、社会交往和家庭关系，通常是持续到青春期和成年期的慢性、重度、发作性抑郁症的开始（Birmaher et al，2007）。单相抑郁症儿童出现自杀意念/行为、药物滥用、法律的问题、身体疾病和早孕的风险更高（Birmaher et al）。大约2 - 4%的儿童患有重度抑郁症或心境恶劣障碍，5 - 10%的儿童和青少年患有亚综合征抑郁症状（Birmaher et al）。由于儿童抑郁症的患病率以及与当前和未来功能缺陷的关系，儿童抑郁症值得进行治疗研究。治疗包括药物和心理治疗干预，尽管两者在12岁及以下儿童中有很大的局限性。最近的一项荟萃分析发现，氟西汀是唯一一种在减少儿童抑郁方面具有显著经验支持的抗抑郁药物，但对治疗后出现的自杀意念/行为的担忧导致美国食品药品监督管理局强制要求在该年龄组中使用抗抑郁药物的黑框警告（Bridge et al，2007）。关于抗抑郁药使用对发育影响的纵向数据不可用。这些担忧引发了人们对替代疗法的兴趣，包括膳食补充剂，特别是欧米茄-3脂肪酸（？3）。治疗心境障碍的研究？3是有希望的（Schacter et al，2005）;然而，仅在儿童中进行了一项RCT，结果为阳性（Nemets et al，2006）。来自其他临床人群（ADHD、青少年抑郁、焦虑和儿童中的广泛性发育障碍）的发现表明组合治疗是有利的（Aman等人，2009年; MTA合作小组，1999年a，B，2004年a，B; TADS小组，2007年; Walkup等人，2008年）。然而，令人惊讶的是，很少有人知道心理治疗对12岁及以下临床抑郁症儿童的有效性。认知行为疗法（CBT）的随机对照试验（RCT）是通过学校项目对情绪症状升高的儿童进行的，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体/家庭治疗，用于临床转诊的可诊断抑郁症儿童（Kovacs et al，2006; Tompson et al，2007）;然而，尚未完成RCT。现有的研究支持将有关抑郁症的心理教育，支持和技能培养结合起来，以减少抑郁症状（Birmaher等人）。我们以前开发和测试心理教育心理治疗（PEP）为8-12岁的儿童情绪障碍。目前的研究比较？3，PEP，以及它们的组合，安慰剂补充剂和主动监测（AM）在一个为期12周的试验60名儿童单相抑郁症。在整个12周试验期间，参与者在参与前一个月不得参与研究以外的抑郁症治疗。主要目标是确定：1）a）在24个月内招募60名参与者的可行性; B）在12周的试验中保留参与者; 2）？3、PEP和联合治疗。次要目标是探索随时间变化的反应曲线、介质和调节剂、广泛结果变量的治疗反应、治疗依从性和副作用。这项试点研究？3、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.