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Dual Orexin Receptor Antagonist

Suvorexant for Post-Traumatic Stress Disorder

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC, Salisbury, NC
Targeting 2 different conditionsSuvorexant +1 morePhase 4RecruitingLed by Sabra S Inslicht, PhDResearch Sponsored by VA Office of Research and Development

Study Summary

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

Eligible Conditions
  • Post Traumatic Stress Disorder
  • Sleep Disorders

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have trouble sleeping, as indicated by a score higher than 14 on a sleep evaluation test.

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)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
FDA approved

Find a site

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,553 Previous Clinical Trials
2,887,781 Total Patients Enrolled
Sabra S Inslicht, PhDPrincipal Investigator
San 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
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’ve only tried atarax for sleep or behavioral interventions.
Patient
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.
~34 spots leftby Dec 2024
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