A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change in Subjective Total Sleep Time - Acute
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of suvorexant, added to existing medications, for treatment-resistant insomnia in individuals with bipolar disorder. The investigators hypothesize that participants receiving suvorexant for one week will experience significantly greater improvement in sleep duration compared to participants receiving placebo.
详细描述
Participants will be randomized to receive double-blind suvorexant or placebo for one week, after which all participants will receive open treatment with suvorexant for three months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult outpatients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder (296.70), bipolar II disorder (296.89), or bipolar disorder not otherwise specified (296.80), with concurrent insomnia related to bipolar disorder (307.42).
- •Currently taking ≥ 1 prescription psychotropic medication (hypnotic agents, anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for management of bipolar disorder.
- •Subjective total sleep time (sTST) < 6 hours on ≥ 1 night during the prior week.
排除标准
- •Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (YMRS) total score ≥
- •Current (past 6 months) alcohol or substance use disorder.
- •Current psychosis.
- •Patients who are actively suicidal or evaluated as being a high suicide risk.
- •Women who are currently pregnant or breastfeeding.
- •Clinically significant abnormalities on baseline laboratory tests (comprehensive metabolic panel, fasting lipid panel, Complete Blood Count (CBC) with differential, thyroid stimulating hormone).
- •Presence of any unstable and/or potentially confounding neurological and/or medical disorder.
研究组 & 干预措施
Suvorexant
50% of enrolled participants will be randomly assigned to receive double-blind suvorexant for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights.
Following the one-week double-blind, placebo-controlled phase, 100% of participants will receive open-label suvorexant for 3 months, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the remainder of 3 months.
干预措施: Suvorexant (Drug)
Placebo
50% of enrolled participants will be randomly assigned to receive double-blind placebo pill for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Subjective Total Sleep Time - Acute
时间窗: baseline and week 1 of double-blind, placebo-controlled phase
Measured by self-report electronic sleep diary. Change is calculated as week 1 value minus week 0 value.
次要结局
- Subjective Total Sleep Time - Subchronic(week 1 and month 3 of open treatment phase)
- Change in Objective Total Sleep Time - Subchronic(week 1 and month 3 of open treatment phase)
- Change in Objective Total Sleep Time - Acute(baseline and week 1 of double-blind, placebo-controlled phase)
研究者
Po W Wang
Clinical Professor, Psychiatry and Behavioral Sciences
Stanford University