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Recruiting NCT06333990

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

Phase III Interventional Mild Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quetiapine Fumarate, TAU.
Who it may be relevant to
Registry conditions: Mild Traumatic Brain Injury. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug Quetiapine Fumarate
    Quetiapine is an atypical antipsychotic approved by the FDA for the treatment of schizophrenia, bipolar disorder, and as an adjunct to treat major depression. It has a broad spectrum of actions at dopaminergic (D1, D2, D3 and D4), serotonergic (5-HT2A, 5-HT2C and 5-HT7), adrenergic (α1), histaminic (H1) and muscarinic (mACh), and partial agonist at 5-HT1A receptors.
  • Drug TAU
    Standard of care psychotropic medications for treatment of patients with mTBI.

Primary outcome measures

  • Neurobehavioral Symptom Inventory [Time frame: 2 weeks]
  • World Health Organization Disability Assessment Scale [Time frame: 30 days]
  • World Health Organization Quality of Life BREF [Time frame: 2 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • New Mexico VA Healthcare System — Albuquerque
  • South Texas Veterans Healthcare System — San Antonio

Identifiers

NCT: NCT06333990 · 20220796HU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗