Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-03-01

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.

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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.

Conditions

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Insomnia Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Suvorexant

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.

Group Type EXPERIMENTAL

Suvorexant

Intervention Type DRUG

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Suvorexant

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Belsomra

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No