PROlonGed ExpoSure Sertraline



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:12/9/2017
Start Date:November 2011
End Date:May 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Randomized Trial of Sertraline, Prolonged Exposure, and Their Combination for Post-traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF).

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, the investigators are examining predictors of response to these two
treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such
treatments. Biological mechanisms of change are also examined including emotion processing
and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the
investigators will examine acceptability of each treatment and reasons for ending treatment.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
4
sites
Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic
Savannah, Georgia 31406
Principal Investigator: Ron Acierno, PhD
Phone: 912-920-0214
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Savannah, GA
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Naomi Simon, MD, MSc
Phone: 617-726-1579
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Boston, MA
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Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan 48105
Principal Investigator: Sheila Rauch, PhD
Phone: 734-222-7441
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Ann Arbor, MI
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VA San Diego Healthcare System
3350 La Jolla Village Dr
San Diego, California 92161
(858) 552-8585
Principal Investigator: Murray Stein, PhD
Phone: 858-642-3878
VA San Diego Healthcare System The VA San Diego Healthcare System (VASDHS) provides high quality...
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mi
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San Diego, CA
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