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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 Stress Disorders, Post-Traumatic and Sleep Initiation and Maintenance Disorders, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 190
- Enrollment target
- 4
- Study locations
NCT03642028: Recruiting Phase 4 study of Stress Disorders, Post-Traumatic and Sleep Initiation and Maintenance Disorders, sponsored by VA Office of Research and Development.
NCT03642028 is a Phase 4 study of Stress Disorders, Post-Traumatic and Sleep Initiation and Maintenance Disorders that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 190 participants, above the 153-participant average among 66 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (24% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03642028, a Phase 4 study of Stress Disorders, Post-Traumatic and Sleep Initiation and Maintenance Disorders, 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.
Primary Outcome
The ISI is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems.
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 |
What NCT03642028 shows while recruiting
NCT03642028 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 153-participant average among 66 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (24% higher).
The record links to 2 conditions, with Stress Disorders, Post-Traumatic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03642028 reports a single indexed study location in 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: Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03642028's enrollment target sits among peer trials
190 15th of 66 higher than 52 of 66 other Stress Disorders, Post-Traumatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress Disorders, Post-Traumatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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