PREVENTION OF RECURRENT POSTPARTUM MAJOR DEPRESSION

预防产后重度抑郁症复发

• 批准号: 2253972
• 负责人: KATHERINE L WISNER
• 金额: $ 24.86万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-06-01 至 1999-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2253972
• 关键词: chemoprevention; clinical trials; drug screening /evaluation; human subject; human therapy evaluation; major depression; mental disorder chemotherapy; mental disorder prevention; nortriptyline; postpartum; relapse /recurrence

Depression which interferes with maternal role functioning occurs in 10 to 15% of women following birth. This disorder causes personal and family suffering at a time when adaptation to the tasks of parenthood is critical. Women who have suffered devastating postpartum major depression fear repeating the experience after subsequent births, but there are no controlled studies regarding prevention of recurrent episodes. Specific Aims: A. The purpose of this study is to conduct a double-blind, randomized clinical trial of the efficacy of the antidepressant nortriptyline in the prevention of recurrent postpartum major depression. The preventive efficacy of nortriptyline will be compared to placebo during the first 20 weeks postpartum in 96 subjects. The hypotheses are: (1) the rate of occurrence of PPMD will be less in the nortriptyline-treated women compared to the placebo-treated women, and (2) of women who become depressed, the time to recurrence will be longer in the nortriptyline- treated women compared to the placebo-treated women. B. These mothers will be followed for the remaining 32 weeks of the first postpartum year. The goals for this naturalistic follow-up period are: (l) to evaluate the adequacy of the length of treatment (20 weeks) in the clinical trial, and (2) to determine if the rate of and time to recurrence after the clinical trial differs among women who took nortriptyline compared to women who took placebo. C. To identify prospectively the clinical predictors of recurrence during the clinical trial.

干扰母体角色功能的抑郁症发生在10至 出生后15％的妇女。这种疾病导致个人和家庭 在适应父母任务的时候痛苦是 批判的。 遭受了产后毁灭性重大抑郁症的妇女 害怕在随后的出生后重复体验，但没有 有关预防复发发作的对照研究。 具体目的： 答：本研究的目的是进行双盲，随机 抗抑郁药在 预防复发产后重度抑郁症。 预防性 在前20个中将将氯替林的功效与安慰剂进行比较 96名受试者的产后周期。 假设是：（1） 在Nortriptyline治疗的妇女中，PPMD的发生较少 与安慰剂治疗的妇女和（2）的妇女相比 沮丧的是，复发时间将在Nortriptyline- 与安慰剂治疗的妇女相比，治疗了妇女。 B.这些母亲将在第一次的剩余32周内遵循 产后年。 这个自然主义后续时期的目标是： （l）评估治疗时间长度的适当性（20周） 临床试验和（2）确定复发的率和时间是否 在临床试验之后，服用Nortriptyline的女性有所不同 与安慰剂的妇女相比。 C.前瞻性地确定复发的临床预测因子 临床试验。