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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 1 week at baseline, and weeks 4, 8, and 12
Awards & highlights

Study 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
Select...
I am not pregnant, planning to become pregnant, or breastfeeding, and I will use birth control.

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
1,609 Previous Clinical Trials
3,306,308 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Suvorexant for public use?

"While Phase 4 trials are not as commonly conducted as earlier phases, this treatment has been approved and is considered safe."

Answered by AI

Are there any other scientific papers that mention Suvorexant?

"As of this date, there are 14 active clinical trials testing Suvorexant. 2 of these studies have progressed to Phase 3. The primary research site is located in Silver Spring, Maryland; however, 71 other medical centres across the country are also conducting research on Suvorexant."

Answered by AI

How many total people are eligible for this research project?

"That is correct, the online clinicaltrials.gov registry shows that this study is open and recruiting patients. This specific trial was posted on 8/30/2019 and updated as recently as 11/10/2022. The research team is looking to enroll a total of 144 patients at 2 different sites."

Answered by AI

Will elderly patients be accepted into this clinical trial?

"Enrolment for this study is open to patients that are between 18-75 years of age."

Answered by AI

Might I be eligible to join this clinical research?

"This study is actively recruiting participants who are currently experiencing sleeplessness. In order to be eligible, individuals must meet the following criteria: 18-75 years of age, US military service history, able to read and understand English, ability to provide written informed consent, Criterion A event meets DSM-5 criteria, PTSD symptoms >3 months duration as indexed by a CAPS-5 12 and a partial PTSD diagnosis at screening, Insomnia indicated by an ISI score > 14, Sertraline, Paroxetine, Fluoxetine, Fluvoxamine, Citalopram or Escitalopram."

Answered by AI

Are there any current vacancies for this research project?

"This is an ongoing clinical trial that was originally posted on August 30th, 2019 and has been actively recruiting patients since. The most recent edit occurred on November 10th, 2020."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
San Francisco VA Medical Center, San Francisco, CA
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
VA Long Beach Healthcare System, Long Beach, CA
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’ve tried sleep meds don’t work. I’ve only tried atarax for sleep or behavioral interventions.
PatientReceived no prior treatments
My ptsd is effecting every aspect of my life beginning w night terrors that don’t allow me to sleep. No sleep at all for Periods of time.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
2019. "Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03642028.
All > Sleep Disorders > Belsomra
~18 spots leftby Dec 2024
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