Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD)
Neurofunctional Markers of SSRI Treatment Response in PTSD
1 other identifier
interventional
65
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2008
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
June 3, 2014
CompletedJune 3, 2014
May 1, 2014
3.4 years
June 17, 2008
September 9, 2013
May 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Arm 1
OTHERIntervention-Paroxetine
Arm 2
NO INTERVENTIONNo Intervention
Interventions
Eligibility Criteria
You may qualify if:
- Veterans with clinical diagnosis of post-traumatic stress disorder from combat related to deployment to Afghanistan/Iraq (Operation Enduring Freedom/Operation Iraqi Freedom)
You may not qualify if:
- Intolerance or sensitivity to paroxetine
- Major medical or neurologic illness
- Current psychotropic medication or active psychotherapy treatment
- Other major psychiatric illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
Chicago, Illinois, 60611, United States
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48113, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. K Luan Phan
- Organization
- Jesse Brown VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
K. Luan Phan, MD
Jesse Brown VA Medical Center, Chicago, IL
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 19, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
June 3, 2014
Results First Posted
June 3, 2014
Record last verified: 2014-05