Clinical trial NCT02527564: Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder
Official title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Bipolar Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-08-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Subjective Total Sleep Time - Acute
timeFrame: baseline and week 1 of double-blind, placebo-controlled phase
Secondary outcomes:
measure: Change in Objective Total Sleep Time - Acute
timeFrame: baseline and week 1 of double-blind, placebo-controlled phase
measure: Subjective Total Sleep Time - Subchronic
timeFrame: week 1 and month 3 of open treatment phase
measure: Change in Objective Total Sleep Time - Subchronic
timeFrame: week 1 and month 3 of open treatment phase
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Po Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: