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

Last updated: July 8, 2025
Sponsor: Foundation for Advancing Veterans' Health Research
Overall Status: Active - Recruiting

Phase

3

Condition

Brain Injury

Neurologic Disorders

Treatment

TAU

Quetiapine Fumarate

Clinical Study ID

NCT06333990
20220796HU
  • Ages 18-65
  • All Genders

Study 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 posttraumatic stress disorder (PTSD).

Eligibility Criteria

Inclusion

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 SymptomInventory (NSI). Six months or more must elapse between the injury and Screening.mTBI diagnosis will be determined using the provisional diagnostic conventionrecommended by the VA/DoD requiring loss of consciousness, or a period of alteredconsciousness, or posttraumatic amnesia;

  3. Be stable (i.e., no dose changes for > 1 month) on at least three CNS activepsychotropic medications prescribed for symptom relief or psychiatric treatment.

  4. Have posttraumatic symptoms measured by PTSD Checklist for DSM-5 (PCL-5) score ≥25.

Exclusion

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 medicaldetoxification or inpatient hospitalization within 6 months of screening.

  6. Reporting suicidal ideation of type 4 or 5 in the Columbia Suicide Severity RatingScale (CSSRS) in the past 3 months prior to screening or at screening or baselinevisit (i.e. active suicidal thought with method and intent but without specificplan, or active suicidal thought with method, intent, and plan); or homicidalideation with intent or plan to harm others within 90 days or suicide attempt; orsuicidal behavior within 6 months prior to screening.

(Note: Study psychiatrist will be immediately notified when SI or HI intent ispositive)

  1. Current or known history of cardiac arrhythmia or QTc interval ≥ 470 milliseconds.

  2. Pregnant or lactating women and those of child-bearing potential not using areliable method of contraception will be excluded from participating in the study.

Study Design

Total Participants: 146
Treatment Group(s): 2
Primary Treatment: TAU
Phase: 3
Study Start date:
July 09, 2024
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • New Mexico VA Healthcare System

    Albuquerque, New Mexico 87108
    United States

    Active - Recruiting

  • South Texas Veterans Healthcare System

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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