NCT06333990

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Foundation for Advancing Veterans' Health Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-07-09
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2024-03-27
• Last updated: 2025-07-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study