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Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia

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ClinicalTrials.gov Identifier: NCT03034018
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hadine Joffe, MD MSc, Brigham and Women's Hospital

Brief Summary:
The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.

Condition or disease Intervention/treatment Phase
Insomnia Drug: suvorexant Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women
Actual Study Start Date : May 25, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Suvorexant

Arm Intervention/treatment
Experimental: suvorexant
suvorexant 10-20 mg taken at bedtime for four weeks
Drug: suvorexant
10-20 mg taken at bedtime for four weeks
Other Name: Belsomra

Placebo Comparator: placebo
placebo taken at bedtime for four weeks
Drug: placebo
placebo taken at bedtime for four weeks




Primary Outcome Measures :
  1. Change in ISI score [ Time Frame: 4 weeks ]
    Change in Insomnia Severity Index (ISI) score



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Peri- or postmenopausal women
  • 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:

  • Diagnosis of other primary sleep disorders
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034018


Contacts
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Contact: Aleta Wiley, MPH 6170525-9627 awiley1@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Aleta Wiley, MPH    617-525-9627    awiley1@bwh.harvard.edu   
Principal Investigator: Hadine Joffe, MD, MSc         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Hadine Joffe, MD MSc Brigham and Women's Hospital

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Responsible Party: Hadine Joffe, MD MSc, Executive Director, Connors Center for Women's Health and Gender Biology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03034018     History of Changes
Other Study ID Numbers: 2016P002667
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hadine Joffe, MD MSc, Brigham and Women's Hospital:
insomnia
hot flashes
menopause
suvorexant
belsomra

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Hot Flashes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Signs and Symptoms
Suvorexant
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action