Status:
COMPLETED
Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy
Lead Sponsor:
Duke University
Collaborating Sponsors:
GlaxoSmithKline
Massachusetts General Hospital
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD. However, although these interventions can be helpful, many patients remain symptomatic despite initial trea...
Detailed Description
This is a systematic controlled study examining the use of augmentation with pharmaotherapy for PTSD patients remaining symptomatic despite CBT (exposure therapy). The aims of the study include examin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00215163
Start Date
December 1 2002
End Date
June 1 2006
Last Update
May 30 2013
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California at San Diego
San Diego, California, United States, 92093
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Duke University Medical Center
Durham, North Carolina, United States, 27705
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19122