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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-traumatic Stress Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1

Intervention-Paroxetine

Group Type OTHER

Paroxetine

Intervention Type DRUG

Paroxetine 20-40mg po QD for 12 weeks

Arm 2

No Intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Paroxetine

Paroxetine 20-40mg po QD for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Paxil (brand name)

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes