Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

NCT02527564 | Completed Phase 4 Results

• 1 other identifier: 53208
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Objective Total Sleep Time - Acute

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

• Subjective Total Sleep Time - Subchronic

  week 1 and month 3 of open treatment phase

• Change in Objective Total Sleep Time - Subchronic

  week 1 and month 3 of open treatment phase

Study Arms (2)

Suvorexant

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Suvorexant DRUG

Also known as: Belsomra

Suvorexant

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Bipolar Disorder

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Results Point of Contact

• Title: Po W. Wang
• Organization: Stanford University

wangp0@stanford.edu

650-723-2483

Study Officials

• Po Wang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 19, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: October 6, 2022
• Results First Posted: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)