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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
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Po W Wang, Stanford University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Bipolar Disorder Drug: Suvorexant Drug: Placebo Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Suvorexant

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Drug: Suvorexant
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.
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Currently taking ≥ 1 prescription psychotropic medication (hypnotic agents, anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for management of bipolar disorder.
  3. Subjective total sleep time (sTST) < 6 hours on ≥ 1 night during the prior week.

Exclusion Criteria:

  1. Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (YMRS) total score ≥ 12.
  2. Current (past 6 months) alcohol or substance use disorder.
  3. Current psychosis.
  4. Patients who are actively suicidal or evaluated as being a high suicide risk.
  5. Women who are currently pregnant or breastfeeding.
  6. Clinically significant abnormalities on baseline laboratory tests (comprehensive metabolic panel, fasting lipid panel, Complete Blood Count (CBC) with differential, thyroid stimulating hormone).
  7. Presence of any unstable and/or potentially confounding neurological and/or medical disorder.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Po Wang, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Po W Wang, Stanford University:
Study Protocol and Statistical Analysis Plan  [PDF] October 8, 2020

More Information
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Responsible Party: Po W Wang, Clinical Professor, Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT02527564    
Other Study ID Numbers: 53208
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
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Bipolar Disorder
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Bipolar and Related Disorders
 Suvorexant
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action