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

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
Foundation for Advancing Veterans' Health Research
Study ID
NCT06333990
Phase
PHASE3
Status
Recruiting
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Conditions

  • Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Quetiapine Fumarate — DRUG
    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.
  • TAU — DRUG
    Standard of care psychotropic medications for treatment of patients with mTBI.

Study Details

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).

Key Dates

Start date
Jul 9, 2024
Status verified
Jul 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Quetiapine
    Quetiapine will be cross-tapered up to a maximum dose of 200 mg (as tolerated) as other standard of care medications are discontinued.
  • Active Comparator: Treatment As Usual (TAU)
    Participants in the TAU group will have doses adjusted over the same period as indicated by usual care criteria.

Primary Outcome Measure

Neurobehavioral Symptom Inventory [ Time Frame: 2 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
New Mexico VA Healthcare SystemAlbuquerqueNew Mexico87108
Jordyn L Filkins
[email protected]
(505)-265-1711
Jessica Veleta
[email protected]
(505)-265-1711
South Texas Veterans Healthcare SystemSan AntonioTexas78229
Lizette Aviles
[email protected]
361-277-5486
Suchada Hill
[email protected]

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