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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00700999
First received: June 17, 2008
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Post-traumatic Stress Disorder
Drug: Paroxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Neurofunctional Markers of SSRI Treatment Response in PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 65
Study Start Date: October 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Intervention-Paroxetine
Drug: Paroxetine
Paroxetine 20-40mg po QD for 12 weeks
Other Name: Paxil (brand name)
No Intervention: Arm 2
No Intervention

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700999

Locations
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
Chicago, Illinois, United States, 60611
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48113
Sponsors and Collaborators
Investigators
Principal Investigator: K. Luan Phan, MD Jesse Brown VA Medical Center, Chicago, IL
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00700999     History of Changes
Other Study ID Numbers: MHBA-002-08S
Study First Received: June 17, 2008
Results First Received: September 9, 2013
Last Updated: May 28, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014