RecruitingPhase 3NCT06333990

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

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


Sponsor

Foundation for Advancing Veterans' Health Research

Enrollment

146 participants

Start Date

Jul 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether quetiapine — a medication used for psychiatric conditions — can help veterans who continue to experience persistent symptoms after a mild traumatic brain injury (concussion). These ongoing symptoms, called post-concussive syndrome, can include memory problems, sleep issues, anxiety, and irritability. **You may be eligible if...** - You are a veteran between ages 18 and 65 - You have a confirmed diagnosis of mild traumatic brain injury (mTBI) and ongoing post-concussive symptoms, at least 6 months after the injury - You are currently on at least three stable psychiatric or neurological medications - You have significant PTSD-related symptoms (PCL-5 score of 25 or higher) **You may NOT be eligible if...** - You have a moderate or severe TBI, or major dementia - You have a known allergy or significant adverse reaction to quetiapine - You are pregnant, breastfeeding, or planning pregnancy - You have certain serious heart, liver, or metabolic conditions that would make quetiapine unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQuetiapine 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.

DRUGTAU

Standard of care psychotropic medications for treatment of patients with mTBI.


Locations(2)

New Mexico VA Healthcare System

Albuquerque, New Mexico, United States

South Texas Veterans Healthcare System

San Antonio, Texas, United States

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NCT06333990


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