Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
NCT ID: NCT03034018
Last Updated: 2022-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2017-05-25
2020-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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suvorexant
suvorexant 10-20 mg taken at bedtime for four weeks
suvorexant
10-20 mg taken at bedtime for four weeks
placebo
placebo taken at bedtime for four weeks
placebo
placebo taken at bedtime for four weeks
Interventions
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suvorexant
10-20 mg taken at bedtime for four weeks
placebo
placebo taken at bedtime for four weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes
* Some awakenings co-occur with a hot flash
* Score on the Insomnia Severity Index (ISI) measure ≥15
* Hot flashes present, including at night
Exclusion Criteria
* Shift workers
* Current or expected use of hypnotic medications
* Current major depressive episode
* Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
* Current alcohol/substance use disorder
* Obesity
* Renal or hepatic disease
* Pregnancy or breastfeeding
* Recent malignancy
* Recent surgery
* Neurological disorder or cardiovascular disease raising safety concerns
* Medical instability considered to interfere with study procedures
* Concomitant medications with drug interaction or co-administration concerns
* Contraindications or allergic responses to suvorexant
* Recent or planned travel across time zones
* Excessive coffee or cigarette use
40 Years
65 Years
FEMALE
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Hadine Joffe, MD MSc
Executive Director, Connors Center for Women's Health and Gender Biology
Principal Investigators
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Hadine Joffe, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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Rahman SA, Nathan MD, Wiley A, Crawford S, Cohn AY, Harder JA, Grant LK, Erickson A, Srivastava A, McCormick K, Bertisch SM, Winkelman JW, Joffe H. A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women. Sleep. 2022 Mar 14;45(3):zsac007. doi: 10.1093/sleep/zsac007.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016P002667
Identifier Type: -
Identifier Source: org_study_id
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