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NCT03642028 · ClinicalTrials.gov registry record · Phase 4
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
A Phase 4 study of Sleep Initiation and Maintenance Disorders and Stress Disorders, Posttraumatic, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 190
- Enrollment target
- 4
- Study locations
NCT03642028 is a Phase 4 study of Sleep Initiation and Maintenance Disorders and Stress Disorders, Posttraumatic that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 190 participants, below the 280-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (32% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT03642028, a Phase 4 study of Sleep Initiation and Maintenance Disorders and Stress Disorders, Posttraumatic, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 190 participants
- Enrollment target
- 4
- Study locations
Study Summary
Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health conditions, such as metabolic syndrome, inflammation, and cardiovascular disease. The orexin neuropeptide system underlies both sleep and stress reactivity. Suvorexant, a drug that reduces orexin, improves sleep in civilians, but has not yet been tested in Veterans with PTSD. This study will test whether suvorexant can improve sleep disturbances and PTSD symptoms in Veterans. Suvorexant may benefit Veterans by improving sleep quickly while also reducing PTSD symptoms over the long term, and with fewer side effects that were common in previous medications used to treat these conditions. Improving Veterans' sleep and PTSD symptoms could lead to better emotional and physical well-being, quality of life, relationships, and functioning.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Suvorexant
Study Locations (4)
California
- VA Long Beach Healthcare System, Long Beach, CA - Long Beach
- San Francisco VA Medical Center, San Francisco, CA - San Francisco
North Carolina
- Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC - Salisbury
South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2019-08-30 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03642028
The ClinicalTrials.gov registry entry for NCT03642028 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 280-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (32% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sleep Initiation and Maintenance Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03642028 reports 4 study locations spanning 3 distinct geographic areas - top geographies include California, North Carolina, South Carolina.
Frequently Asked Questions
What is clinical trial NCT03642028 about?
NCT03642028 is a clinical study titled "Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress". Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health c...
What is the current status of trial NCT03642028?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 190 participants. The study started on 2019-08-30. Estimated completion is 2025-12-31.
What conditions does trial NCT03642028 study?
This clinical trial studies the following conditions: Sleep Initiation and Maintenance Disorders, Stress Disorders, Posttraumatic.
What interventions are being tested in trial NCT03642028?
The interventions under investigation include: Placebo (OTHER), Suvorexant (DRUG).
Who is sponsoring clinical trial NCT03642028?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03642028 being conducted?
This trial has 4 study locations across California, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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