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Antipsychotic

Quetiapine for Post-Concussion Syndrome

Phase 3
Recruiting
Research Sponsored by Foundation for Advancing Veterans' Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare the effectiveness of quetiapine alone to the usual medication management for veterans with mild traumatic brain injury and posttraumatic stress disorder who are undergoing rehabilitation therapy.

Who is the study for?
This trial is for veterans aged 18-65 with mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD), who have been stable on at least three CNS psychotropic medications for over a month. Participants must have PTSD symptoms and report post-concussion syndrome (PCS) symptoms, with the mTBI occurring at least six months prior to screening.
What is being tested?
The study compares quetiapine monotherapy—a medication that can affect neurotransmitters in the brain—to standard treatment as usual (TAU). It's designed to see if quetiapine is more effective in managing symptoms of mTBI and PTSD in veterans undergoing rehabilitation therapy.
What are the potential side effects?
Quetiapine may cause drowsiness, dry mouth, dizziness, constipation, weight gain, or blurred vision. Some people might also experience changes in blood pressure or abnormal heart rhythms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran aged 18-65 seeking treatment for a mild traumatic brain injury.
Select...
I have had a mild traumatic brain injury and still experience symptoms after six months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neurobehavioral Symptom Inventory
World Health Organization Disability Assessment Scale
World Health Organization Quality of Life BREF

Side effects data

From 2009 Phase 4 trial • 376 Patients • NCT00672490
13%
Constipation
8%
Weight Increased
8%
Nausea
7%
Tremor
7%
Dizziness
6%
Extrapyramidal Symptom
6%
Upper respiratory tract infection
5%
Liver function test abnormal
5%
Vomiting
5%
Somnolence
5%
Diarrhoea
5%
Hypersomnia
4%
Hypothyroidism
4%
Hyperlipidemia
4%
Tachycardia
3%
Fatigue
3%
Dry mouth
2%
Palpitations
1%
Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Quetiapine Fumarate Used as Adjunct Therapy
Quetiapine Fumarate Used as Mono-Therapy

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: QuetiapineExperimental Treatment1 Intervention
Quetiapine will be cross-tapered up to a maximum dose of 200 mg (as tolerated) as other standard of care medications are discontinued.
Group II: Treatment As Usual (TAU)Active Control1 Intervention
Participants in the TAU group will have doses adjusted over the same period as indicated by usual care criteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quetiapine Fumarate
2011
Completed Phase 4
~1020

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioOTHER
476 Previous Clinical Trials
92,829 Total Patients Enrolled
Foundation for Advancing Veterans' Health ResearchLead Sponsor
2 Previous Clinical Trials
180 Total Patients Enrolled
Biomedical Research Institute of New MexicoOTHER
10 Previous Clinical Trials
2,121 Total Patients Enrolled
~97 spots leftby Jun 2028
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