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RECRUITING
NCT06333990
PHASE3

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

Sponsor: Foundation for Advancing Veterans' Health Research

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

146

Start Date

2024-07-09

Completion Date

2028-06

Last Updated

2025-07-11

Healthy Volunteers

No

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.

Locations (2)

New Mexico VA Healthcare System

Albuquerque, New Mexico, United States

South Texas Veterans Healthcare System

San Antonio, Texas, United States