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Dual Orexin Receptor Antagonist

Suvorexant for PTSD-Related Sleep Disturbances

Phase 4
Recruiting
Led By Sabra S Inslicht, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of child-bearing potential must not be pregnant or have plans for pregnancy or breastfeeding during the study and must use a medically acceptable method of birth control
Be older than 18 years old
Must not have
Manic or psychotic episode in the last 5 years
Prohibited medications: benzodiazepines, strong CYP3A inhibitors, Digoxin, CNS depressants when co-administered with suvorexant, and concomitant use of suvorexant with specific inhibitors or inducers of CYP3A
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 1 week at baseline, and weeks 4, 8, and 12
Awards & highlights

Summary

This trial will test whether suvorexant, a drug that reduces orexin, can improve sleep disturbances and PTSD symptoms in Veterans.

Who is the study for?
This trial is for US Veterans aged 18-75 with PTSD and sleep disturbances, not currently experiencing severe mental health crises or substance abuse. Participants must have stable medication use if applicable, no recent trauma exposure, and cannot be pregnant or planning pregnancy.Check my eligibility
What is being tested?
The study tests Suvorexant's effectiveness in improving sleep and reducing PTSD symptoms compared to a placebo. It explores whether targeting the orexin system can provide relief with fewer side effects than previous treatments.See study design
What are the potential side effects?
Suvorexant may cause drowsiness, headaches, dizziness, dry mouth, coughing or wheezing; however it aims to present fewer side effects than earlier medications used for these conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant, planning to become pregnant, or breastfeeding, and I will use birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a manic or psychotic episode in the last 5 years.
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I am not taking benzodiazepines, strong CYP3A inhibitors, Digoxin, CNS depressants with suvorexant, or specific CYP3A affecting drugs.
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I have been diagnosed with narcolepsy.
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I am currently taking benzodiazepines, strong CYP3A inhibitors, or Digoxin.
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I have not had serious thoughts or actions of harming myself or others in the last 3 months.
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I have a brain disorder or illness affecting my brain function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from 1 week at baseline, and weeks 4, 8, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from 1 week at baseline, and weeks 4, 8, and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Insomnia Severity Index (ISI)
Secondary outcome measures
Post-Traumatic Stress Disorder
Wrist Actigraphy
Other outcome measures
Clinical Global Impression (CGI)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SuvorexantExperimental Treatment1 Intervention
Suvorexant is a dual orexin receptor antagonist that is FDA approved to treat insomnia.
Group II: Identical PlaceboPlacebo Group1 Intervention
Visibly matched, equally weighted placebo tablets. In addition to matching in appearance and weight, they will have identical packaging and labeling as randomized, blinded study medication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant
2016
Completed Phase 4
~2120

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,835 Total Patients Enrolled
Sabra S Inslicht, PhDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
1 Previous Clinical Trials
111 Total Patients Enrolled

Media Library

Suvorexant (Dual Orexin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03642028 — Phase 4
Post-Traumatic Stress Disorder Research Study Groups: Identical Placebo, Suvorexant
Post-Traumatic Stress Disorder Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT03642028 — Phase 4
Suvorexant (Dual Orexin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03642028 — Phase 4
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT03642028 — Phase 4
~11 spots leftby Dec 2024