Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Bipolar Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Suvorexant

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Suvorexant; Other Names: Belsomra
Placebo Comparator: 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.	Drug: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Po Wang, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Bipolar and Related Disorders; Sleep Initiation and Maintenance Disorders; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; Sleep Aids, Pharmaceutical; Orexin Receptor Antagonists; Suvorexant
• Other Study ID Numbers: 53208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No