Quetiapine for Post-Concussion Syndrome After Mild Traumatic Brain Injury

This study is looking at whether a medication called Quetiapine Fumarate can help veterans who have post-concussion syndrome (PCS) after a mild traumatic brain injury (mTBI). PCS symptoms can include problems with thinking, memory, and mood. Researchers will compare Quetiapine Fumarate to standard care medications (TAU) for these symptoms. You might be able to join if you are a veteran between 18 and 65 years old, have been diagnosed with mTBI, and have PCS symptoms that started at least six months after your injury. The study will measure how well treatments work by looking at your symptoms, how well you can do daily activities, and your quality of life. The current recruitment status is unclear.

Study design
This is a Phase III randomized pragmatic clinical trial involving 146 participants. It has two groups, with participants randomly assigned to receive either Quetiapine Fumarate or standard care medications.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at 2 weeks and 30 days after treatment.

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NCT06333990

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

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Foundation for Advancing Veterans' Health Research
~146 participants
Updated 2025-07-11 on ClinicalTrials.gov
What's tested:Quetiapine FumarateTAU

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurobehavioral Symptom Inventory
Measured over 2 weeks
+2 more outcomes measured
Mild Traumatic Brain Injury
2 sites across 2 states
New Mexico1
Texas1

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  • Neurobehavioral Symptom Inventory2 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 Scale30 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 BREF2 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.