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

Phase 4

Completed

• Conditions: Post-traumatic Stress Disorder
• Interventions: Drug: Paroxetine

• Registration Number: NCT00700999
• Lead Sponsor: US Department of Veterans Affairs

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Study Start: 2008-10
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-09-09
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-28
• Last Update Submitted: 2014-05-28
• Results First Posted: 2014-06-03
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Paroxetine	Intervention-Paroxetine

Primary Outcome Measures

Name	Time	Method
Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)	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.

Trial Locations

Locations (3)

Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL; 🇺🇸 Chicago, Illinois, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI; 🇺🇸 Ann Arbor, Michigan, United States

Jesse Brown VA Medical Center, Chicago, IL; 🇺🇸 Chicago, Illinois, United States