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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: muhammad.baig@va.gov
• Phone: 210-617-5300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Cognitive behavioral therapy for insomnia in people with mild traumatic brain injury

  This study will try cognitive behavioral therapy for insomnia (CBT-I) to see if it helps adults with mild traumatic brain injury sleep better and improve daily functioning.

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• Passive neurosensory reintegration training to help recovery after mild traumatic brain injury

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• Early Intervention for Adults with Ongoing Post-Concussion Symptoms after Mild TBI

  This study tests a package of physical/occupational therapy and telephonic psychoeducation to help adults recover after a mild traumatic brain injury.

  Recruiting University Medical Center Groningen · Groningen · NCT07341074

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.