Neurofunctional Markers of SSRI Treatment Response in PTSD
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 65
- Locations
- 3
- Primary Endpoint
- Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)
Study Overview
Brief Summary
The purpose of this study is to examine if treatment of post-traumatic stress disorder in combat veterans with paroxetine changes brain responses as measured by functional magnetic resonance imaging and if brain responses can predict who will get better with treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Veterans with clinical diagnosis of post-traumatic stress disorder from combat related to deployment to Afghanistan/Iraq (Operation Enduring Freedom/Operation Iraqi Freedom)
Exclusion Criteria
- •Intolerance or sensitivity to paroxetine
- •Major medical or neurologic illness
- •Current psychotropic medication or active psychotherapy treatment
- •Other major psychiatric illness
Arms & Interventions
Arm 1
Intervention-Paroxetine
Intervention: Paroxetine (Drug)
Outcomes
Primary Outcomes
Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)
Time Frame: Baseline and 12 weeks
Mean percent change in brain response in the prefrontal cortex during an emotion reappraisal task in the treatment (paroxetine) group and in the Combat Exposed Control group. Target areas are analyzed from fMRI scans which were completed before participants receive treatment and again after participants received 12 weeks of treatment with paroxetine (20-40mg QD). Combat Exposed Control participants received an fMRI scan after signing initial consent and again 12 weeks later.
Secondary Outcomes
No secondary outcomes reported