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Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Primary Purpose

Insomnia, Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Suvorexant
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suvorexant

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Subjective Total Sleep Time - Acute
Measured by self-report electronic sleep diary. Change is calculated as week 1 value minus week 0 value.

Secondary Outcome Measures

Change in Objective Total Sleep Time - Acute
Measured by actigraphy. Change is calculated as week 1 value minus week 0 value.
Subjective Total Sleep Time - Subchronic
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
Measured by actigraphy. Change is measured as the month 3 value minus the week 1 value.

Full Information

First Posted
August 17, 2015
Last Updated
October 3, 2022
Sponsor
Stanford University
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02527564
Brief Title
Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder
Official Title
A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suvorexant
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Suvorexant
Other Intervention Name(s)
Belsomra
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Subjective Total Sleep Time - Acute
Description
Measured by self-report electronic sleep diary. Change is calculated as week 1 value minus week 0 value.
Time Frame
baseline and week 1 of double-blind, placebo-controlled phase
Secondary Outcome Measure Information:
Title
Change in Objective Total Sleep Time - Acute
Description
Measured by actigraphy. Change is calculated as week 1 value minus week 0 value.
Time Frame
baseline and week 1 of double-blind, placebo-controlled phase
Title
Subjective Total Sleep Time - Subchronic
Description
Measured by self-report electronic sleep diary. Change is calculated as the month 3 value minus the week 1 value
Time Frame
week 1 and month 3 of open treatment phase
Title
Change in Objective Total Sleep Time - Subchronic
Description
Measured by actigraphy. Change is measured as the month 3 value minus the week 1 value.
Time Frame
week 1 and month 3 of open treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po Wang, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

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