CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 223 enrolled
Drug / intervention
Sertraline +1 moredrug
Likely dose
Sertraline 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01524133
NCT01524133Phase 4Completed
CompareCT.gov

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

VA Ann Arbor Healthcare System·interventional·Posted Feb 1, 2012·Updated Feb 28, 2018

In Brief

A Phase 4 clinical trial evaluating Sertraline and Prolonged Exposure Therapy for Posttraumatic Stress Disorder. Completed, enrolled 223 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPosttraumatic Stress Disorder
CountriesUnited States
CollaboratorsU.S. Army Medical Research and Development Command

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2012
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2016
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 14.4 years ago

Interventions

Sertralinedrug

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.

Prolonged Exposure Therapybehavioral

up to 13 sessions of prolonged exposure