PROlonGed ExpoSure Sertraline

Posttraumatic Stress Disorder Clinical Trial

— PROGrESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524133
• Other study ID #: PROGrESS
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2012
• Last updated: January 30, 2018
• Start date: November 2011
• Est. completion date: May 2017

Study information

• Verified date: January 2018
• Source: VA Ann Arbor Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	Veterans Affairs Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	VA San Diego Healthcare System	San Diego	California
United States	Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic	Savannah	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
VA Ann Arbor Healthcare System	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)	Total Score; Range 0-136 with increasing PTSD severity as scores increase	24 weeks
Secondary	Patient Health Questionnaire-15	PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe	24 weeks