Department of Psychological and Brain Sciences, the University of Iowa, Iowa City, IA, United States.
Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, United States; Department of Medicine, Warren Alpert Medical School of Brown University, Providence, RI, United States.
J Affect Disord. 2019 Feb 15;245:524-532. doi: 10.1016/j.jad.2018.10.361. Epub 2018 Oct 31.
The purpose of the present study was to test the efficacy of sertraline and Interpersonal Psychotherapy (IPT) relative to pill placebo in a two site randomized controlled trial over a period of 12 weeks. It was hypothesized that sertraline and IPT would be more efficacious than pill placebo with respect to depression and social adjustment.
162 breastfeeding and non-breastfeeding women experiencing a major depressive episode in the first year postpartum from two sites in Iowa and Rhode Island were randomly assigned to IPT, sertraline-clinical management (CM), or pill placebo-CM. CM included infant-focused psychoeducation. Interview-based and self-report measures of depression and social adjustment were obtained at baseline, 4-weeks, 8-weeks, and 12-weeks of treatment. Linear mixed effects regression (LMER) was used for the longitudinal data analysis.
There was no significant effect for treatment condition associated with the primary outcome measure, the HamD-17, but there was a significant effect for sertraline-CM relative to the IPT and placebo conditions over the duration of the trial based on the General Depression scale of the Inventory of Depression and Anxiety Symptoms. There was a main effect for time in that study subjects across all three conditions showed significant improvement for the duration of the trial.
Limitations of the present study included significant non-engagement with assigned condition and differential effects of IPT across the two study sites.
There was improvement for all postpartum women in all conditions. The results do suggest that active interventions with or without medication delivered over a period of twelve weeks can lead to significant improvement in depression and social adjustment among postpartum women. ClinicalTrials.gov identifier: NCT00602355.
本研究的目的是在为期 12 周的两站点随机对照试验中，测试舍曲林和人际心理治疗（IPT）相对于安慰剂丸在治疗产后第一年出现重度抑郁症的女性的疗效。假设舍曲林和 IPT 相对于安慰剂丸在治疗抑郁和社会适应方面更有效。
来自爱荷华州和罗得岛州两个地点的 162 名正在母乳喂养和非母乳喂养的产后第一年出现重度抑郁症发作的女性，被随机分配到 IPT、舍曲林-临床管理（CM）或安慰剂丸-CM。CM 包括以婴儿为中心的心理教育。在基线、4 周、8 周和 12 周的治疗中，使用访谈和自我报告的抑郁和社会适应测量。线性混合效应回归（LMER）用于纵向数据分析。
治疗条件与主要结局测量（HamD-17）之间没有显著的效果，但在整个试验期间，舍曲林-CM 相对于 IPT 和安慰剂条件具有显著的效果，基于抑郁和焦虑症状清单的一般抑郁量表。时间有一个主要影响，即研究对象在所有三种条件下在整个试验期间都表现出显著的改善。
本研究的局限性包括对指定条件的显著不参与和 IPT 在两个研究地点的差异效果。
所有条件下的所有产后女性都有改善。结果表明，在 12 周的时间内，积极的干预措施（无论是否有药物治疗）都可以显著改善产后女性的抑郁和社会适应。临床试验注册编号：NCT00602355。
