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

This study is currently recruiting participants.

Verified by Department of Veterans Affairs, September 2009

First Received: June 17, 2008 Last Updated: September 4, 2009 History of Changes

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00700999

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 IV

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Neurofunctional Markers of SSRI Treatment Response in PTSD

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans Post-Traumatic Stress Disorder

Drug Information available for: Paroxetine Paroxetine hydrochloride 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 ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: paroxetine Paroxetine 20-40mg po QD for 12 weeks

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

Contacts

Contact: Amy Kennedy, MSW	(734) 845-3035	akennedy@med.umich.edu
Contact: Hedieh Briggs, MSW	(734) 764-9527	hedieh@med.umich.edu

Locations

United States, Michigan
VA Ann Arbor Healthcare System	Recruiting
Ann Arbor, Michigan, United States, 48113
Contact: Amy Kennedy, MSW 734-845-3035 akennedy@med.umich.edu
Principal Investigator: K. Luan Phan, MD

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

K. Luan Phan, MD

VA Ann Arbor Healthcare System

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs ( Phan, K. Luan - Principal Investigator )
Study ID Numbers:	MHBA-002-08S
Study First Received:	June 17, 2008
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00700999 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Neurotransmitter Agents
Anxiety Disorders
Mental Disorders
Psychotropic Drugs
Stress Disorders, Post-Traumatic
Stress

Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Paroxetine
Antidepressive Agents
Serotonin
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Paroxetine
Serotonin Uptake Inhibitors
Stress Disorders, Traumatic
Pharmacologic Actions

Pathologic Processes
Serotonin Agents
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Stress Disorders, Post-Traumatic
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 11, 2009