Status:
COMPLETED
PROlonGed ExpoSure Sertraline
Lead Sponsor:
VA Ann Arbor Healthcare System
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The current research study aims to compare the effectiveness of two proven treatments for posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their combination. In addition,...
Eligibility Criteria
Inclusion
- Patient is an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) combat veteran with chronic posttraumatic stress disorder (PTSD) or significant PTSD symptoms (Clinician Administered Posttraumatic Stress Disorder Scale \[CAPS\] \>= 50) of at least 3 months duration
Exclusion
- Current, imminent risk of suicide (as indicated on C-SSRS)
- Active psychosis
- Alcohol or substance dependence in the past 8 weeks
- Unable to attend regular appointments
- Prior intolerance or failure of adequate trial of prolonged exposure (PE) or sertraline (SERT) (defined as at least 2 months of SERT at least 100mg/day)
- Medical illness likely to result in hospitalization or for which treatments are contraindicated (based on lab results, medical history and physical exam)
- Serious cognitive impairment (as evidenced by cognitive impairment felt likely to interfere with the ability to participate meaningfully in the study)
- Concurrent antidepressants or antipsychotics
- Pregnant females
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT01524133
Start Date
November 1 2011
End Date
May 1 2017
Last Update
February 28 2018
Active Locations (4)
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1
VA San Diego Healthcare System
San Diego, California, United States, 92161
2
Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic
Savannah, Georgia, United States, 31406
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105