Using quetiapine to help veterans with post concussive syndrome after mild brain injuries

A Randomized Clinical Trial of Quetiapine to Reduce Post Concussive Syndrome Polypharmacy

This study tests if the medication quetiapine can help veterans aged 18-65 recover from post concussive syndrome after mild brain injuries better than standard treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Foundation for Advancing Veterans' Health Research (Academic / other)
• Locations: 2 sites (Albuquerque, New Mexico and 1 other locations)
• Trial ID: NCT06333990 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the effectiveness of quetiapine monotherapy compared to standard treatment for veterans experiencing post concussive syndrome following mild traumatic brain injury. The study involves two sites and focuses on veterans aged 18-65 who have been stable on multiple psychotropic medications. Participants will be assessed for their symptoms using established inventories to determine the impact of quetiapine on their recovery.

Who should consider this trial

Good fit: Ideal candidates are male or female veterans aged 18-65 with a diagnosis of mild traumatic brain injury and post concussive syndrome symptoms.

Not a fit: Patients with moderate or severe traumatic brain injury or major psychiatric disorders such as schizophrenia or bipolar disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate symptoms of post concussive syndrome in veterans, improving their quality of life.

How similar studies have performed: Other studies have explored the use of quetiapine for various psychiatric conditions, but this specific application for post concussive syndrome in veterans is relatively novel.

Eligibility criteria

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.

Where this trial is running

Albuquerque, New Mexico and 1 other locations

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

Study contacts

• Study coordinator: Muhammad R Baig, MD

Conditions Mild Traumatic Brain Injury; Post Concussive Syndrome; Posttraumatic Stress Disorder; Polypharmacy; Quetiapine; Veterans