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

Primary Purpose

Post-traumatic Stress Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Paroxetine
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post-traumatic Stress Disorder

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
  • Jesse Brown VA Medical Center, Chicago, IL
  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Arm 1

Arm 2

Arm Description

Intervention-Paroxetine

No Intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2008
Last Updated
May 28, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00700999
Brief Title
Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD)
Official Title
Neurofunctional Markers of SSRI Treatment Response in PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Intervention-Paroxetine
Arm Title
Arm 2
Arm Type
No Intervention
Arm Description
No Intervention
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Other Intervention Name(s)
Paxil (brand name)
Intervention Description
Paroxetine 20-40mg po QD for 12 weeks
Primary Outcome Measure Information:
Title
Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. Luan Phan, MD
Organizational Affiliation
Jesse Brown VA Medical Center, Chicago, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Jesse Brown VA Medical Center, Chicago, IL
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48113
Country
United States

12. IPD Sharing Statement

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

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