Phase 4 N=65 Basic Science

Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD)

Post-traumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00700999 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI) — -.92; .07 percent change in BOLD signal — p=.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Paroxetine (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)	-.92; .07	.001 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00700999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.