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OpenTrials
Completed

NCT Number: NCT00700999

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

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paroxetine

Drug

Paroxetine 20-40mg po QD for 12 weeks

Other names: Paxil (brand name)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Neurofunctional Markers of SSRI Treatment Response in PTSD

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 19, 2008
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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