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Phase 4 N=48 Randomized Triple-blind Treatment

Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Insomnia · Bipolar Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02527564 ↗
Enrolled (actual)
48
Serious AEs
1.1%
Results posted
Oct 2022
Primary outcome: Primary: Change in Subjective Total Sleep Time - Acute — 7.04; 7.03; 7.53; 7.20 hours — p=0.10

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Suvorexant (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Mar 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Subjective Total Sleep Time - Acute		 7.04; 7.03; 7.53; 7.20; 0.49; 0.17 0.10
SECONDARY
Change in Objective Total Sleep Time - Acute		 6.46; 9.50; 7.20; 10.10; 0.74; 0.61 0.035 sig
SECONDARY
Subjective Total Sleep Time - Subchronic		 7.24; 7.25; 0.01 0.97
SECONDARY
Change in Objective Total Sleep Time - Subchronic		 8.69; 9.58; 0.88 0.28

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02527564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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