A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Total Sleep Time
研究概览
简要总结
Depression with ongoing insomnia is a common clinical presentation with patients. Clinical data suggests that patients with insomnia that receive concomitant treatment with a sleep aid experience a more robust antidepressant response along with a quicker response. The purpose of this clinical study is to compare the effectiveness of the FDA-approved insomnia medication suvorexant, also known as Belsomra®, as add-on treatment to an antidepressant to that of placebo plus antidepressant treatment in patients with depression and residual or ongoing insomnia.
详细描述
Many patients with depression suffer from residual insomnia. This study is a six week, randomized, double-blind, placebo-controlled, trial to study suvorexant augmentation of continuing antidepressant therapy against placebo with continuing antidepressant therapy. Patient volunteers must be on a stable antidepressant treatment and will remain on this treatment for the duration of the study. Patient volunteers that qualify and enroll in the clinical trial will either receive suvorexant 10 mg/day and may have it adjusted to a dose of either 15 mg or 20 mg/day. Treatment is for a total of six weeks in addition to a clinical follow-up visit.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written Informed Consent
- •Diagnosis of depression (MDD)
- •Currently on antidepressant
- •Healthy and/or stable medically
排除标准
- •unwilling to discontinue current use of sedative hypnotics/sleep aids/benzodiazepines or over the counter sleep aids/supplements
- •currently using other psychotropics other than antidepressants
- •at risk of self harm or a suicide attempt within the past 12 months
- •history or presence of psychotic disorders
- •known hypersensitivity to suvorexant
- •presence of any other sleep disorder other than residual insomnia of depression
研究组 & 干预措施
Suvorexant
suvorexant 10mg/day, 15mg/day or 20mg/day augmentation of FDA-approved antidepressant treatment
干预措施: suvorexant (Drug)
Placebo
no augmentation of FDA-approved antidepressant treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Total Sleep Time
时间窗: Six weeks ( baseline to end of treatment)
assessment of total amount of time spent sleeping
次要结局
- Insomnia Severity Index (ISI)(Six weeks ( baseline to end of treatment))
- Sheehan Disability Scale(Six weeks ( baseline to end of treatment))
- Perceived Deficits Questionnaire (PDQ)(Six weeks ( baseline to end of treatment))
- Hamilton Depression Rating Scale(Six weeks ( baseline to end of treatment))
- Wake After Sleep Onset (WASO)(Six weeks ( baseline to end of treatment))
- Sleep Latency (SL)(Six weeks ( baseline to end of treatment))