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: 7259949
• 负责人: SCOTT P STUART
• 金额: $ 88.14万
• 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/7259949
• 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50万名美国女性。除了妇女遭受的痛苦外，它对妇女的家庭及其发育中的婴儿也具有深远的影响。尽管PPD具有公共卫生的意义，但进行了相对较少的研究来确定哪些治疗方法有效。在PPD的整个抑郁严重程度上，没有使用抗抑郁药的安慰剂对照试验进行的。因此，抗抑郁药对PPD的疗效尚不清楚。相比之下，对PPD治疗的人际心理治疗（IPT）进行了更彻底的研究。尽管有证据支持IPT与候补名单控制相比的疗效，但尚未将PPD的IPT与安慰剂或抗抑郁药相比。为了解决这种缺乏数据，我们建议通过从社区，诊所招募的PPD和来自爱荷华州和罗德岛两个地点的产后医院的PPD代表性样本进行随机临床试验。该项目的目的是比较三种治疗条件的功效：1）单独的药物治疗（舍曲林 +临床管理）； 2）独自一人； 3）安慰剂（PILL安慰剂 +临床管理）。我们假设在为期12周的试验结束时，对于抑郁症状和社会功能，舍曲林和IPT都将比安慰剂更有效。除了研究这种急性结果外，我们还将使用非效率测试将两种活性治疗的功效进行比较，以将治疗与IPT和舍曲林进行比较。我们还将检查主动治疗的特定作用。由于焦虑是PPD的共同特征，因此我们将检验以下假设：舍曲林治疗将比IPT和安慰剂在减轻焦虑症状方面更有效。由于IPT是专门设计用于解决人际关系功能和社会支持的，因此我们将检验以下假设：IPT将比Sertraline和安慰剂在改善社会功能方面更有效。这项研究与妇女及其家人的公共卫生高度相关。拟议的研究的发现将提供经验数据，以支持PPD治疗，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保健做出明智的风险/利益决定的能力。