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Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT02527564
Recruitment Status : Recruiting
First Posted : August 19, 2015
Last Update Posted : October 4, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Shefali Miller, Stanford University

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

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

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



Primary Outcome Measures :
  1. subjective total sleep time - acute [ Time Frame: week 1 of double-blind, placebo-controlled phase ]
    measured by self-report electronic sleep diary


Secondary Outcome Measures :
  1. objective total sleep time - acute [ Time Frame: week 1 of double-blind, placebo-controlled phase ]
    measured by actigraphy

  2. subjective total sleep time - subchronic [ Time Frame: month 1, month 2, and month 3 of open treatment phase ]
    measured by self-report electronic sleep diary

  3. objective total sleep time - subchronic [ Time Frame: month 1, month 2, and month 3 of open treatment phase ]
    measured by actigraphy



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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 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, CBC with differential, thyroid stimulating hormone).
  7. Presence of any unstable and/or potentially confounding neurological and/or medical disorder.

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


Contacts
Contact: Lauren Chang, B.S. 650-498-8459 laurensc@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Lauren Chang, B.S.    650-498-8459    laurensc@stanford.edu   
Sponsors and Collaborators
Stanford University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Shefali Miller, MD Stanford University

Responsible Party: Shefali Miller, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02527564     History of Changes
Other Study ID Numbers: 53208
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Sleep Initiation and Maintenance Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Suvorexant
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs