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OpenTrials
Completed

NCT Number: NCT02527564

Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

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.

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Key information

Conditions

Insomnia Bipolar Disorder Bipolar and Related Disorders Dyssomnias Mental Disorders Mood Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suvorexant

Drug

Other names: Belsomra

Placebo

Drug

Primary outcomes

  1. Change in Subjective Total Sleep Time - Acute

    Time frame: baseline and week 1 of double-blind, placebo-controlled phase

    Measured by self-report electronic sleep diary. Change is calculated as week 1 value minus week 0 value.

Secondary outcomes

  1. Change in Objective Total Sleep Time - Acute

    Time frame: baseline and week 1 of double-blind, placebo-controlled phase

    Measured by actigraphy. Change is calculated as week 1 value minus week 0 value.

  2. Subjective Total Sleep Time - Subchronic

    Time frame: week 1 and month 3 of open treatment phase

    Measured by self-report electronic sleep diary. Change is calculated as the month 3 value minus the week 1 value

  3. Change in Objective Total Sleep Time - Subchronic

    Time frame: week 1 and month 3 of open treatment phase

    Measured by actigraphy. Change is measured as the month 3 value minus the week 1 value.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2015
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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