Actively Recruiting
Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)
Led by Foundation for Advancing Veterans' Health Research · Updated on 2025-07-11
146
Participants Needed
2
Research Sites
203 weeks
Total Duration
On this page
Sponsors
F
Foundation for Advancing Veterans' Health Research
Lead Sponsor
T
The University of Texas Health Science Center at San Antonio
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female veterans seeking treatment for mild traumatic brain injury (mTBI), aged 18-65 years
- Diagnosed with mTBI and experiencing post-concussive symptoms reported on the Neurobehavioral Symptom Inventory (NSI), with at least six months since injury
- Stable (no dose changes for over 1 month) on at least three CNS-active psychotropic medications for symptom relief or psychiatric treatment
- Posttraumatic symptoms with PTSD Checklist for DSM-5 (PCL-5) score of 25 or higher
You will not qualify if you...
- Moderate or severe traumatic brain injury (TBI) or major neurocognitive disorder (dementia)
- Diagnosis of schizophrenia, bipolar disorder, schizoaffective disorder, or requiring inpatient hospitalization currently or within past 6 months
- Use of any antipsychotics or prohibited medications within the past month
- Known intolerance to quetiapine or unstable heart, lung, liver, kidney, blood, or endocrine conditions; diabetes; severe sleep apnea; or seizure disorder
- Severe substance use disorder requiring medication treatment, detoxification, or hospitalization within 6 months
- Suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (CSSRS) in past 3 months or recent suicidal or homicidal behavior
- History of cardiac arrhythmia or QTc interval of 470 milliseconds or higher
- Pregnant or lactating women or women of child-bearing potential not using reliable contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
New Mexico VA Healthcare System
Albuquerque, New Mexico, United States, 87108
Actively Recruiting
2
South Texas Veterans Healthcare System
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
M
Muhammad R Baig, MD
CONTACT
L
Lizette Aviles, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here