Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Launched by STANFORD UNIVERSITY · Aug 18, 2015

Keywords

ClinConnect Summary

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.

Gender

ALL

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.