Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy

Completed · Phase 2/Phase 3

Conditions studied: Stress Disorders, Post-Traumatic

In brief

Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD. However, although these interventions can be helpful, many patients remain symptomatic despite initial treatment. In this study, we will examine the relative efficacy of the addition of paroxetine-CR compared to placebo for patients remaining symptomatic despite a brief and intensive course of cognitive-behavioral therapy (CBT).

Key facts

Study ID

NCT00215163

Run by

Duke University

People needed

17

Starts

2002-12-01

Expected to finish

2006-06-01

Last updated by the study team

2013-05-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of PTSD as defined by DSM-IV criteria
• Patients must have remained symptomatic (CGI-S > or = 3) and a score of at least 6 on the SPRINT after a minimum of 7 sessions of prolonged exposure (delivered within 6 weeks) to be eligible for randomized treatment.

You may not qualify if…

• Serious medical illness or instability for which hospitalization may be likely within the next 3 months
• Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception
• Concurrent use of other psychotropic medications
• Lifetime diagnosis of schizophrenia or any other psychotic disorder, mental retardation, organic mental disorders, or bipolar disorder
• Obsessive-Compulsive Disorder, eating disorders, or alcohol/substance abuse disorders within the last 6 months
• A current primary diagnosis of major depression, dysthymia, social anxiety disorder, and generalized anxiety disorder
• A history of hypersensitivity or poor response to paroxetine or those using antidepressants, buspirone, or beta-blockers within 2 weeks of randomization
• Concurrent dynamic or supportive psychotherapy if started within 2 months prior to onset of study entry

Where it is running

• University of California at San Diego — San Diego, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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