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

Recruiting Phase 3 Interventional Study
Mild Traumatic Brain Injury
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
146 (estimated)
Sponsor
Foundation for Advancing Veterans' Health Research · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female veterans seeking treatment for mTBI, aged 18-65 years 2. 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 …
Contacts

Muhammad R Baig, MD

210-617-5300

muhammad.baig@va.gov

CONTACT

Lizette Aviles, BS

361-277-5486

lizette.aviles@va.gov

CONTACT