Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Stanford University61 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Insomnia Bipolar Disorder

Interventions

SuvorexantDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline and week 1 of double-blind, placebo-controlled phase

Secondary Outcomes

Change in Objective Total Sleep Time - Acute

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

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

Time frame: 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.

Time frame: week 1 and month 3 of open treatment phase

Data from ClinicalTrials.gov

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