Mild Traumatic Brain InjuryPhase 3NCT06333990
Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)
A Phase 3 study testing Quetiapine Fumarate and TAU in people with Mild Traumatic Brain Injury, run by Foundation for Advancing Veterans' Health Research at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Quetiapine Fumarate and TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jul 2024to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female veterans seeking treatment for mTBI, aged 18-65 years
- 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;
- 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.
- Have posttraumatic symptoms measured by PTSD Checklist for DSM-5 (PCL-5) score ≥25.
Who cannot join
- Moderate or severe TBI, or major neurocognitive disorder (dementia).
- Meet DSM-5 criteria for schizophrenia, bipolar disorder, schizoaffective disorder, or requiring inpatient hospitalization currently or within past 6 months.
- Currently taking any antipsychotics or prohibited medication within the past month .
- 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.
- Substance use disorder severe enough to require medication treatment or medical detoxification or inpatient hospitalization within 6 months of screening.
- 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.
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- (Note: Study psychiatrist will be immediately notified when SI or HI intent is positive)
- Current or known history of cardiac arrhythmia or QTc interval ≥ 470 milliseconds.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
New Mexico VA Healthcare System
Albuquerque, New Mexico, 87108
Jordyn L Filkins, (505)-265-1711 ext. 5235, jordyn.filkins@va.gov
Jessica Veleta, (505)-265-1711 ext. 7164, jessica.veleta@va.gov
- Recruiting
South Texas Veterans Healthcare System
San Antonio, Texas, 78229
Lizette Aviles, 361-277-5486, Lizette.Aviles@va.gov
Suchada Hill, suchada.hill@va.gov
About this study
Official title: A Randomized Clinical Trial of Quetiapine to Reduce Post Concussive Syndrome Polypharmacy
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
- Mild Traumatic Brain Injury
- Being tested
- Quetiapine Fumarate, TAU
- Keywords
- Post Concussive Syndrome (PCS), Posttraumatic Stress Disorder (PTSD), Polypharmacy, Quetiapine, Veterans
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine FumarateDrug
Also called Seroquel
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.
TAUDrug
Also called Treatment As Usual
Standard of care psychotropic medications for treatment of patients with mTBI.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Experimental | Quetiapine will be cross-tapered up to a maximum dose of 200 mg (as tolerated) as other standard of care medications are discontinued. Receives: Drug: Quetiapine Fumarate |
| Treatment As Usual (TAU) | Active comparator | Participants in the TAU group will have doses adjusted over the same period as indicated by usual care criteria. Receives: Drug: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
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.
Measured: 30 days
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start9 Jul 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Advancing Veterans' Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, Biomedical Research Institute of New Mexico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333990
- Sponsor's protocol ID
- 20220796HU
- Status last verified
- Jul 2025
- First submitted
- 20 Mar 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified IPD will be shared with the research community through Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Quetiapine to Reduce Post Concussive Syndrome Polypharmacy
- ClinicalTrials.gov ID
- NCT06333990
- Acronym / sponsor ID
- 20220796HU
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Post Concussive Syndrome (PCS), Posttraumatic Stress Disorder (PTSD), Polypharmacy, Quetiapine, Veterans
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Foundation for Advancing Veterans' Health ResearchUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, Biomedical Research Institute of New Mexico
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Experimental | Drug: Quetiapine FumarateQuetiapine will be cross-tapered up to a maximum dose of 200 mg (as tolerated) as other standard of care medications are discontinued. |
| Treatment As Usual (TAU) | Active comparator | Drug: TAUParticipants in the TAU group will have doses adjusted over the same period as indicated by usual care criteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female veterans seeking treatment for mTBI, aged 18-65 years
- 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;
- 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.
- Have posttraumatic symptoms measured by PTSD Checklist for DSM-5 (PCL-5) score ≥25.
Key exclusion criteria (9 listed)
- Moderate or severe TBI, or major neurocognitive disorder (dementia).
- Meet DSM-5 criteria for schizophrenia, bipolar disorder, schizoaffective disorder, or requiring inpatient hospitalization currently or within past 6 months.
- Currently taking any antipsychotics or prohibited medication within the past month .
- 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.
- Substance use disorder severe enough to require medication treatment or medical detoxification or inpatient hospitalization within 6 months of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine FumarateAlso: SeroquelQuetiapine 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 | Quetiapine |
| TAUAlso: Treatment As UsualStandard of care psychotropic medications for treatment of patients with mTBI. | Drug | Treatment As Usual (TAU) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Yes. All de-identified IPD will be shared with the research community through Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine Fumarate and TAU in people with Mild Traumatic Brain Injury, run by Foundation for Advancing Veterans' Health Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad R Baig, MD (210-617-5300 ext. 18244, muhammad.baig@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavioral Symptom Inventory (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.