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Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 2 sitesv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Primary and study completion dates: Mar 2028 to Jun 2028
    • Start date changed from estimate of Apr 2024 to Jul 9, 2024
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD).
Trial Details
NCT Number NCT06333990
Lead Sponsor Foundation for Advancing Veterans' Health Research
Collaborators: The University of Texas Health Science Center at San Antonio, Biomedical Research Institute of New Mexico
Conditions
(from sponsor)		 Mild Traumatic Brain Injury
Related terms Brain Concussion, Post-Concussion Syndrome, Stress Disorders, Post-Traumatic
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov