Placebo Controlled Trial of Sertraline and IPT for Postpartum Depression

描述(申请人提供)：产后抑郁症(PPD)是一种严重的精神疾病，每年影响超过50万美国女性。除了妇女所经历的痛苦之外，它还对妇女家庭及其发育中的婴儿产生了深远的影响。尽管产后抑郁具有公共卫生意义，但确定哪些治疗方法有效的研究相对较少。目前还没有针对产后抑郁严重程度的所有范围使用抗抑郁药物的安慰剂对照试验。因此，抗抑郁药对产后抑郁的疗效尚不清楚。相比之下，人际心理疗法(IPT)在PPD的治疗中得到了更深入的研究。尽管有证据支持IPT与等待名单对照相比的疗效，但IPT治疗PPD尚未与安慰剂或抗抑郁药进行比较。为了解决这种数据的缺乏，我们建议进行一项随机临床试验，从社区、诊所和爱荷华州和罗德岛州两个地点的产后日间医院招募300名具有代表性的PPD门诊患者。这个项目的目的是比较三种治疗条件的疗效：1)单独的药物治疗(舍曲林临床管理)；2)单独的IPT；以及3)安慰剂(药物安慰剂临床管理)。我们假设在为期12周的试验结束时，舍曲林和IPT在抑郁症状和社会功能方面都比安慰剂有效得多。除了调查这一急性结局，我们还将使用非劣势测试来检查这两种积极治疗的疗效，以将治疗与IPT和舍曲林进行比较。我们还将检查积极治疗的具体效果。由于焦虑是PPD的常见特征，我们将检验舍曲林治疗在减少焦虑症状方面明显比IPT和安慰剂有效的假设。由于IPT是专门为解决人际功能和社会支持而设计的，我们将检验IPT在改善社会功能方面比舍曲林和安慰剂更有效的假设。这项研究与妇女及其家庭的公共健康高度相关。这项拟议研究的结果将为产后抑郁的治疗提供经验数据支持，因此将对产后抑郁的临床管理产生重大影响。这项研究的数据还将提高妇女及其医生就产后精神卫生保健做出明智的风险/利益决定的能力。

DESCRIPTION (provided by applicant): Postpartum depression (PPD) is a serious mental illness that affects more than 500,000 US women every year. In addition to the suffering experienced by women, it has profound effects on women's families and their developing infants. Despite the public health significance of PPD, relatively little research has been conducted to determine which treatments are efficacious. There have been no placebo-controlled trials using antidepressant medication for the entire range of depression severity of PPD. Consequently, the efficacy of antidepressants for PPD is unknown. In contrast, Interpersonal Psychotherapy (IPT) has been more thoroughly studied for the treatment for PPD. Although there is evidence supporting the efficacy of IPT compared to a waiting list control, IPT for PPD has not yet been compared to either placebo or antidepressant medication. To address this lack of data, we propose to conduct a randomized clinical trial with a representative sample of 300 outpatients with PPD recruited from the community, from clinics, and from a Postpartum Day Hospital at two sites in Iowa and Rhode Island. The aim of this project is to compare the efficacy of three treatment conditions: 1) Pharmacotherapy alone (Sertraline + Clinical Management); 2) IPT alone; and 3) Placebo (Pill Placebo + Clinical Management). We hypothesize that both sertraline and IPT will be significantly more efficacious than placebo with respect to depressive symptomatology and social functioning at the end of the 12-week trial. In addition to investigating this acute outcome, we will also examine the efficacy of the two active treatments using a non-inferiority test to compare treatment with IPT and sertraline. We will also examine the specific effects of the active treatments. Since anxiety is a common feature of PPD, we will test the hypothesis that treatment with sertraline will be significantly more efficacious than IPT and placebo in reducing anxiety symptoms. Since IPT is specifically designed to address interpersonal functioning and social support, we will test the hypothesis that IPT will be more efficacious than sertraline and placebo in improving social functioning. The study is highly relevant to the public health of women and their families. Findings from the proposed research will provide empirical data in support of treatments for PPD, and will therefore have a significant impact on the clinical management of PPD. The data from this study will also improve the ability of women and their physicians to make informed risk/benefit decisions about their postpartum mental health care.