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

Post-traumatic Stress Disorder Clinical Trial

Official title:

Neurofunctional Markers of SSRI Treatment Response in PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700999
• Other study ID #: MHBA-002-08S
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2008
• Last updated: May 28, 2014
• Start date: October 2008
• Est. completion date: March 2012

Study information

• Verified date: May 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Paroxetine
Paroxetine 20-40mg po QD for 12 weeks

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL	Chicago	Illinois
United States	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)	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.	Baseline and 12 weeks	No