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: April 25, 2012
Last verified: April 2012
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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: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Neurofunctional Markers of SSRI Treatment Response in PTSD |
Resource links provided by NLM:
Drug Information available for:
Paroxetine
Paroxetine hydrochloride
Paroxetine hydrochloride hemihydrate
Paroxetine Mesylate
U.S. FDA Resources
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Change in brain response measured by functional magnetic resonance imaging [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 41 |
| 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 |
Drug: paroxetine
Paroxetine 20-40mg po QD for 12 weeks
Other Name: Paxil (brand name)
|
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
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 |
| Last Updated: | April 25, 2012 |
| 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 May 19, 2013