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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00700999
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Information provided by (Responsible Party):
VA Office of Research and Development ( 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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Drug: Paroxetine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neurofunctional Markers of SSRI Treatment Response in PTSD
Study Start Date : October 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Arm 1
Drug: Paroxetine
Paroxetine 20-40mg po QD for 12 weeks
Other Name: Paxil (brand name)

No Intervention: Arm 2
No Intervention

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00700999

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United States, Illinois
Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
Chicago, Illinois, United States, 60611
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48113
Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: K. Luan Phan, MD Jesse Brown VA Medical Center, Chicago, IL
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Responsible Party: US Department of Veterans Affairs Identifier: NCT00700999    
Other Study ID Numbers: MHBA-002-08S
First Posted: June 19, 2008    Key Record Dates
Results First Posted: June 3, 2014
Last Update Posted: June 3, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors