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 |
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.
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
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Naomi Simon, MD, MSc
Phone: 617-726-1579
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Ann Arbor, Michigan 48105
Principal Investigator: Sheila Rauch, PhD
Phone: 734-222-7441
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3350 La Jolla Village Dr
San Diego, California 92161
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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Savannah, Georgia 31406
Principal Investigator: Ron Acierno, PhD
Phone: 912-920-0214
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