Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03642028 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 18, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Enrollment target: 144 to 190v17
  2. Notable Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025 Site details revised at 1 of 4 sitesv16 Show 1 more changeShow less
    • Site details revised at 1 of 4 sites
  3. Minor Study sites: 2 to 4 Eligibility criteria revised · Study description revisedv15 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Eligibility criteria expanded, about 38 wordsv14 See this version in full on ClinicalTrials.gov ↗
  5. Minor Study Status, Referencesv13
Show 11 earlier versionsHide 11 earlier versions
  1. Notable Primary and study completion dates: Sep 30, 2023 to Dec 31, 2024 Eligibility criteria shortened, about 25 wordsv12 Show 1 more changeShow less
    • Eligibility criteria shortened, about 25 words

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Eligibility criteria shortened, about 32 words Site details revised at 1 of 2 sitesv11 Show 1 more changeShow less
    • Site details revised at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Eligibility criteria shortened, about 36 wordsv10 See this version in full on ClinicalTrials.gov ↗
  4. Notable Trial status: Not Yet Recruiting to Recruiting Site details revised at 2 of 2 sitesv9 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  5. Notable Start date: Jun 17, 2019 to Aug 30, 2019v8
  6. Notable Start date: Apr 15, 2019 to Jun 17, 2019v7
  7. Notable Start date: Mar 1, 2019 to Apr 15, 2019v6
  8. Minor Study sites: 1 to 2v5
  9. Notable Start date: Jan 7, 2019 to Mar 1, 2019v4
  10. Minor Study sites: 2 to 1 Collaborators shortened, about 5 wordsv3 Show 1 more changeShow less
    • Collaborators shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  11. Notable Start date: Nov 1, 2018 to Jan 7, 2019 Site contacts updated at 1 of 2 sitesv2 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03642028
Lead Sponsor VA Office of Research and Development
Conditions Sleep Initiation and Maintenance Disorders, Stress Disorders, Posttraumatic
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov