Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02527564

Collaborator

Merck Sharp & Dohme LLC (Industry)

100

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Bipolar Disorder	Drug: Suvorexant Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

subjective total sleep time - acute [week 1 of double-blind, placebo-controlled phase]
measured by self-report electronic sleep diary

Secondary Outcome Measures

objective total sleep time - acute [week 1 of double-blind, placebo-controlled phase]
measured by actigraphy
subjective total sleep time - subchronic [month 1, month 2, and month 3 of open treatment phase]
measured by self-report electronic sleep diary
objective total sleep time - subchronic [month 1, month 2, and month 3 of open treatment phase]
measured by actigraphy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University
Merck Sharp & Dohme LLC

Investigators

Principal Investigator: Po Wang, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Po W Wang, Clinical Professor, Psychiatry and Behavioral Sciences, Stanford University

ClinicalTrials.gov Identifier:

NCT02527564

Other Study ID Numbers:

53208

First Posted:

Aug 19, 2015

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Bipolar Disorder

Suvorexant

Study Results

No Results Posted as of Mar 17, 2021