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

NCT06333990 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-07-11

No results posted yet for this 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).

Conditions

  • Mild Traumatic Brain Injury

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER

  • Biomedical Research Institute of New Mexico

    collaborator OTHER

  • Foundation for Advancing Veterans' Health Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-09
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06333990 on ClinicalTrials.gov