Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Percent of Participants With Depression Remission
研究概览
简要总结
The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.
详细描述
Participants with major depressive disorder and insomnia who meet all study criteria will receive state-of-the-art antidepressant medications and one of two insomnia therapies. The specific therapy for insomnia will be determined by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or desensitization psychotherapy for insomnia. The study physician will select an initial antidepressant medication from a list of three possible medications . If that medication is not helpful, another medication may be tried after 8 weeks or in the event of severe side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for Major Depressive Disorder
- •Between 18 and 75 years of age and adequately fluent in English
- •Meets criteria for an insomnia disorder
排除标准
- •Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
- •People for whom the antidepressant medication(s) provided in the study is not indicated
- •People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
- •People with uncontrolled medical conditions.
- •People with moderate or severe sleep disorders other than insomnia
- •Individuals on a fixed night shift or rotating work schedule that requires a night shift.
- •Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.
研究组 & 干预措施
antidepressant + desensitization
Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
干预措施: Antidepressant (Drug)
antidepressant + desensitization
Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
干预措施: Desensitization Therapy for Insomnia (Behavioral)
antidepressant + cognitive behavioral
Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
干预措施: Antidepressant (Drug)
antidepressant + cognitive behavioral
Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
结局指标
主要结局
Percent of Participants With Depression Remission
时间窗: 16 weeks
Depression remission was defined if both a and b below are satisfied 1. absence of both depressed mood and anhedonia for at least three consecutive weeks 2. no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks
次要结局
- Percentage of Participants in Insomnia Remission(16 weeks)
研究者
Rachel Manber
Professor
Stanford University
