NCT06333990 · Foundation for Advancing Veterans' Health Research
Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)
What this study is about
A two site, 2-treatment group$1, Phase III randomly assigned pragmatic clinical trial evaluating the effectiveness of quetiapine treatment given alone 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).
View original scientific description
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).
Interventions
DRUG
Quetiapine Fumarate
Quetiapine is an atypical antipsychotic approved by the FDA for the treatment of schizophrenia, bipolar disorder, and as an adjunct to treat major depression. It has a broad spectrum of actions at dopaminergic (D1, D2, D3 and D4), serotonergic (5-HT2A, 5-HT2C and 5-HT7), adrenergic (α1), histaminic (H1) and muscarinic (mACh), and partial agonist at 5-HT1A receptors.
DRUG
TAU
Standard of care psychotropic medications for treatment of patients with mTBI.
Primary outcome measures
Neurobehavioral Symptom Inventory
Time frame: 2 weeks
A 22- item, self-report measure of symptoms of postconcussive symptoms severity for the preceding 2 week period. Items are scored on a 5-point scale, and a total score is obtained by summing the 22 symptom items, with higher scores indicate greater symptom severity. The total scores range from 0 - 88.
World Health Organization Disability Assessment Scale
Time frame: 30 days
A 12-item, self-report measure of functional disability for the preceding 30 days. Items are scored on a 5-point scale, and a total score is obtained by summing the 12 activities, with higher scores indicate greater disability. The total scores range from 0 - 48.
World Health Organization Quality of Life BREF
Time frame: 2 weeks
A 26- item, self-report measure to assess functioning and quality of life for the preceding 2 week period. It is a measure of conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, independence, and recreation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female veterans seeking treatment for mTBI, aged 18-65 years 2. Meet mTBI diagnosis and have PCS symptoms reported on the Neurobehavioral Symptom Inventory (NSI). Six months or more must elapse between the injury and Screening. mTBI diagnosis will be determined using the provisional diagnostic convention recommended by the VA/DoD requiring loss of consciousness, or a period of altered consciousness, or posttraumatic amnesia; 3. Be stable (i.e., no dose changes for \> 1 month) on at least three CNS active psychotropic medications prescribed for symptom relief or psychiatric treatment. 4. Have posttraumatic symptoms measured by PTSD Checklist for DSM-5 (PCL-5) score ≥25.
Exclusion criteria
- Moderate or severe TBI, or major neurocognitive disorder (dementia). 2. Meet DSM-5 criteria for schizophrenia, bipolar disorder, schizoaffective disorder, or requiring inpatient hospitalization currently or within past 6 months. 3. Currently taking any antipsychoti
Where
- Albuquerque, New Mexico
- San Antonio, Texas
Collaborators
The University of Texas Health Science Center at San Antonio, Biomedical Research Institute of New Mexico
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 11, 2025 · Source of record for eligibility and locations