NCT01524133

PROlonGed ExpoSure Sertraline

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: VA Ann Arbor Healthcare System · Federal
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Sertraline	Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
BEHAVIORAL	Prolonged Exposure Therapy	up to 13 sessions of prolonged exposure

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-12-01
• Completion: 2017-05-01
• First posted: 2012-02-01
• Last updated: 2018-02-28
• Results posted: 2018-02-28

Locations

4 sites across 1 country: United States