Placebo Controlled Trial of Sertraline and IPT for Postpartum Depression

舍曲林和 IPT 治疗产后抑郁症的安慰剂对照试验

• 批准号: 7496424
• 负责人: SCOTT P STUART
• 金额: $ 105.67万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-14 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7496424
• 关键词: Acute; Address; Affect; Ambulatory Care Facilities; Antidepressive Agents; Anxiety; Beck depression inventory; Benefits and Risks; Caring; Clinic; Clinical; Clinical Management; Communities; Condition; Data; Depressed mood; Diagnosis; Equipment and supply inventories; Family; General Population; Hamilton Rating Scale for Depression; Infant; Infant Development; Inferior; Iowa; Length of Stay; Measures; Mental Depression; Mental Health; Minority; Outcome; Outpatients; Patients; Pharmaceutical Preparations; Pharmacotherapy; Physicians; Placebos; Postpartum Depression; Postpartum Period; Postpartum Women; Psychotherapy; Public Health; Questionnaires; Randomized Clinical Trials; Range; Rate; Recording of previous events; Recruitment Activity; Research; Rhode Island; Sampling; Sertraline; Severities; Severity of illness; Site; Social Adjustment; Social Functioning; Social support; Socioeconomic Status; Symptoms; Testing; Time; Treatment Efficacy; Waiting Lists; Week; Woman; depressive symptoms; design; emotional distress; experience; improved; pill; placebo controlled study; response; severe mental illness; treatment effect; treatment trial; week trial

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.

描述（由申请人提供）：产后抑郁症 (PPD) 是一种严重的精神疾病，每年影响超过 500,000 名美国女性。除了妇女所经历的痛苦之外，它还对妇女的家庭及其正在发育的婴儿产生深远的影响。尽管产后抑郁症对公共卫生具有重要意义，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 PPD 抑郁严重程度的整个范围使用抗抑郁药物的安慰剂对照试验。因此，抗抑郁药对 PPD 的疗效尚不清楚。相比之下，人际关系心理治疗（IPT）对于 PPD 的治疗已得到更深入的研究。尽管有证据支持 IPT 与等待名单对照相比的功效，但尚未将 IPT 治疗 PPD 与安慰剂或抗抑郁药物进行比较。为了解决数据缺乏的问题，我们建议进行一项随机临床试验，从社区、诊所以及爱荷华州和罗德岛州两个地点的产后日间医院招募 300 名产后抑郁症门诊患者作为代表性样本。该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（安慰剂药片 + 临床管理）。我们假设，在 12 周试验结束时，舍曲林和 IPT 在抑郁症状和社会功能方面都比安慰剂更有效。除了研究这种急性结果外，我们还将使用非劣效性检验来检查两种积极治疗的疗效，以比较 IPT 和舍曲林的治疗。我们还将检查积极治疗的具体效果。由于焦虑是 PPD 的一个常见特征，我们将检验这样的假设：舍曲林治疗在减轻焦虑症状方面比 IPT 和安慰剂更有效。由于 IPT 是专门为解决人际功能和社会支持问题而设计的，因此我们将检验 IPT 在改善社会功能方面比舍曲林和安慰剂更有效的假设。该研究与妇女及其家庭的公共卫生高度相关。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就产后心理保健做出明智的风险/效益决策的能力。