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PROlonGed ExpoSure Sertraline

NCT01524133 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2018-02-28

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • VA Ann Arbor Healthcare System

    lead FED

Principal Investigators

  • Sheila Rauch, PhD · VA Ann Arbor Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-12-31
Completion
2017-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01524133 on ClinicalTrials.gov