Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT02527564|
Recruitment Status : Completed
First Posted : August 19, 2015
Results First Posted : October 6, 2022
Last Update Posted : October 6, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Insomnia Bipolar Disorder||Drug: Suvorexant Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||March 1, 2021|
|Actual Study Completion Date :||March 1, 2021|
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.
Other Name: Belsomra
Placebo Comparator: 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.
- Change in Subjective Total Sleep Time - Acute [ Time Frame: 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.
- Change in Objective Total Sleep Time - Acute [ Time Frame: baseline and week 1 of double-blind, placebo-controlled phase ]Measured by actigraphy. Change is calculated as week 1 value minus week 0 value.
- Subjective Total Sleep Time - Subchronic [ Time Frame: week 1 and month 3 of open treatment phase ]Measured by self-report electronic sleep diary. Change is calculated as the month 3 value minus the week 1 value
- Change in Objective Total Sleep Time - Subchronic [ Time Frame: week 1 and month 3 of open treatment phase ]Measured by actigraphy. Change is measured as the month 3 value minus the week 1 value.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (YMRS) total score ≥ 12.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527564
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Po Wang, MD||Stanford University|
Documents provided by Po W Wang, Stanford University:
|Responsible Party:||Po W Wang, Clinical Professor, Psychiatry and Behavioral Sciences, Stanford University|
|Other Study ID Numbers:||
|First Posted:||August 19, 2015 Key Record Dates|
|Results First Posted:||October 6, 2022|
|Last Update Posted:||October 6, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Bipolar and Related Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action