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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02527564
Other study ID # 53208
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2015
Est. completion date March 1, 2021

Study information

Verified date October 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Suvorexant

Placebo


Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline and week 1 of double-blind, placebo-controlled phase
Secondary Change in Objective Total Sleep Time - Acute Measured by actigraphy. Change is calculated as week 1 value minus week 0 value. baseline and week 1 of double-blind, placebo-controlled phase
Secondary 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 week 1 and month 3 of open treatment phase
Secondary Change in Objective Total Sleep Time - Subchronic Measured by actigraphy. Change is measured as the month 3 value minus the week 1 value. week 1 and month 3 of open treatment phase
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