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

Recruiting now · Phase 3

Conditions studied: Mild Traumatic Brain Injury

In brief

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).

Key facts

Study ID

NCT06333990

Run by

Foundation for Advancing Veterans' Health Research

People needed

146

Starts

2024-07-09

Expected to finish

2028-06-01

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• (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.

Where it is running

• New Mexico VA Healthcare System — Albuquerque, New Mexico, United States (enrolling)
• South Texas Veterans Healthcare System — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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