Placebo Controlled Trial of Sertraline and IPT for Postpartum Depression

产后抑郁症（PPD）是一种严重的精神疾病，每年影响超过50万美国妇女。除了妇女遭受的痛苦之外，它还对妇女的家庭及其正在发育的婴儿产生深远的影响。尽管PPD的公共卫生意义，相对较少的研究已经进行，以确定哪些治疗是有效的。目前还没有使用抗抑郁药物治疗PPD的整个抑郁严重程度范围的安慰剂对照试验。因此，抗抑郁药对PPD的疗效尚不清楚。相比之下，人际心理治疗（IPT）已被更彻底地研究用于治疗PPD。虽然有证据支持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物进行比较。为了解决这一缺乏数据的问题，我们建议进行一项随机临床试验，从爱荷华州和罗得岛的两个地点的社区、诊所和产后日间医院招募300名PPD门诊患者。本项目的目的是比较三种治疗条件的疗效：1）单独药物治疗（舍曲林+临床管理）; 2）单独IPT; 3）安慰剂（安慰剂+临床管理）。我们假设在12周试验结束时，舍曲林和IPT在抑郁症的治疗和社会功能方面比安慰剂更有效。除了研究这种急性结局外，我们还将使用非劣效性检验比较IPT和舍曲林治疗，检查两种活性治疗的疗效。我们还将研究积极治疗的具体效果。由于焦虑是PPD的共同特征，我们将检验舍曲林治疗在减轻焦虑症状方面比IPT和安慰剂显著更有效的假设。由于IPT是专门设计来解决人际功能和社会支持，我们将测试的假设，即IPT将更有效地改善社会功能比舍曲林和安慰剂。这项研究与妇女及其家庭的公共健康密切相关。拟议研究的结果将提供支持PPD治疗的经验数据，因此将对PPD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对产后心理健康护理做出明智的风险/受益决定的能力。

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.