Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder

Conditions
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Insomnia, Bipolar Disorder

Intervention / Treatment
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* Drug: Suvorexant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suvorexant<br>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<br> <br> * Other names: Belsomra;|
| Placebo Comparator: Placebo<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |