Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Stanford University

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder; Insomnia

Treatments: Drug: Placebo; Drug: Suvorexant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02527564

53208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 2 patient groups, including a placebo group

Suvorexant

Experimental group

Description:

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.

Treatment:

Drug: Suvorexant

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo