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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified June 2025 by Foundation for Advancing Veterans' Health Research
Sponsor
Foundation for Advancing Veterans' Health Research
Information Provided by (Responsible Party)
Foundation for Advancing Veterans' Health Research
Clinicaltrials.gov Identifier
NCT06333990
Other Study ID Numbers:
20220796HU
First Submitted
March 19, 2024
First Posted
March 26, 2024
Last Update Posted
July 10, 2025
Last Verified
June 2025

ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Mild Traumatic Brain Injury
Drug: Quetiapine FumarateDrug: TAU

Study Design

Study TypeInterventional
Actual Enrollment146 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Randomized Clinical Trial of Quetiapine to Reduce Post Concussive Syndrome Polypharmacy
Study Start DateJuly 8, 2024
Actual Primary Completion Date1yr 10mos from now
Actual Study Completion Date1yr 10mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Quetiapine
Quetiapine will be cross-tapered up to a maximum dose of 200 mg (as tolerated) as other standard of care medications are discontinued.
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.
Treatment As Usual (TAU)
Participants in the TAU group will have doses adjusted over the same period as indicated by usual care criteria.
Drug: TAU
Standard of care psychotropic medications for treatment of patients with mTBI.

Outcome Measures

Primary Outcome Measures
  1. Neurobehavioral Symptom Inventory
    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.
  2. World Health Organization Disability Assessment Scale
    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.
  3. World Health Organization Quality of Life BREF
    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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. 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
1. 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 antipsychotics or prohibited medication within the past month . 4. Known intolerance to quetiapine or a history of clinically unstable heart, lung, liver, renal, hematological, or endocrinological condition, diabetes mellitus, severe sleep apnea and/or seizure disorder. 5. Substance use disorder severe enough to require medication treatment or medical detoxification or inpatient hospitalization within 6 months of screening. 6. Reporting suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months prior to screening or at screening or baseline visit (i.e. active suicidal thought with method and intent but without specific plan, or active suicidal thought with method, intent, and plan); or homicidal ideation with intent or plan to harm others within 90 days or suicide attempt; or suicidal behavior within 6 months prior to screening. (Note: Study psychiatrist will be immediately notified when SI or HI intent is positive) 7. Current or known history of cardiac arrhythmia or QTc interval ≥ 470 milliseconds. 8. Pregnant or lactating women and those of child-bearing potential not using a reliable method of contraception will be excluded from participating in the study.

Contacts and Locations

Sponsors and CollaboratorsFoundation for Advancing Veterans' Health Research
Locations
New Mexico VA Healthcare System | Albuquerque New Mexico, United States, 87108South Texas Veterans Healthcare System | San Antonio Texas, United States, 78229