Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Childhood Depression

描述(申请人提供)：儿童期起病的单相抑郁影响学习成绩、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、严重、间歇性抑郁的开始(Birmaher等人，2007年)。患有单相抑郁的儿童有更高的风险出现自杀念头/行为、药物滥用、法律问题、身体疾病和早孕(Birmaher等人)。大约2%到4%的儿童经历严重抑郁障碍或恶劣心境障碍，5%到10%的儿童和青少年经历亚综合征抑郁症状(Birmaher等人)。由于儿童抑郁症的流行及其与当前和未来重大功能缺陷的关联，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，尽管这两种方法在12岁及以下的儿童中都有很大的局限性。最近的一项荟萃分析发现，氟西汀是唯一一种对减少儿童抑郁有显著经验支持的抗抑郁药物，但对治疗紧急自杀意念/行为的担忧导致食品和药物管理局强制要求在该年龄段使用抗抑郁药物的黑盒警告(Bridge等人，2007年)。没有关于使用抗抑郁剂对发育影响的纵向数据。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(？3)。用？3治疗情绪障碍的研究很有希望(Schacter等人，2005年)；然而，只有一项针对儿童的随机对照试验是阳性的(Nemets等人，2006年)。来自其他临床人群(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等人，2009年；MTA合作小组，1999a，b，2004a，b；TADS团队，2007年；Walkup等人，2008年)。然而，令人惊讶的是，人们对心理治疗对12岁及以下临床抑郁症儿童的有效性知之甚少。认知行为疗法(CBT)的随机对照试验(RCT)是通过以学校为基础的项目进行的，对象是情绪升高的儿童，而不是被诊断为抑郁障碍的临床转诊儿童。一些研究人员开始为临床转诊的患有抑郁症的儿童开发和测试基于手册的个人/家庭疗法(Kovacs等人，2006年；Tompson等人，2007年)；然而，还没有完成随机对照试验。现有的研究支持将有关抑郁的心理教育、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)。目前的研究对60名单相抑郁儿童进行了为期12周的试验，比较了？3、PEP及其组合与安慰剂补充剂和主动监测(AM)的疗效。在为期12周的试验期间，参与者不得从参与前一个月开始参加研究外的抑郁症治疗。主要目标是确定：1)在24个月内招募60名参与者的可行性；b)在12周的试验中留住参与者；以及2)？3、PEP和联合治疗的效果大小。次要目标是探索随时间变化的反应曲线、调节剂和调节剂、各种结果变量的治疗反应、对治疗的坚持和副作用。这项关于？3、PEP和联合治疗的先导性研究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.