Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527564
• Other study ID #: 53208
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: March 1, 2021

Study information

• Verified date: October 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Suvorexant

• Placebo

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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