Bipolar Disorder Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder
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 |
Verified date | October 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Merck Sharp & Dohme LLC |
United States,
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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