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PROlonGed ExpoSure Sertraline (PROGrESS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Sheila Rauch, Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT01524133
First received: January 27, 2012
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Posttraumatic Stress Disorder
Drug: Sertraline
Behavioral: Prolonged Exposure Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by VA Ann Arbor Healthcare System:

Primary Outcome Measures:
  • Posttraumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Posttraumatic stress disorder (PTSD) related psychopathology, including depression, alcohol and substance abuse, and general anxiety [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 441
Study Start Date: November 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sertraline + enhanced medication management (SERT)
24 weeks of sertraline + enhanced medication management
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.
Other Name: Zoloft
Active Comparator: Prolonged Exposure + sertraline (PE/SERT)
Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
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.
Other Name: Zoloft
Behavioral: Prolonged Exposure Therapy
up to 13 sessions of prolonged exposure
Active Comparator: Prolonged Exposure + placebo (PE/PLB)
Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Behavioral: Prolonged Exposure Therapy
up to 13 sessions of prolonged exposure

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524133

Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
United States, Georgia
Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic
Savannah, Georgia, United States, 31406
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
VA Ann Arbor Healthcare System
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Sheila Rauch, PhD VA Ann Arbor Healthcare System
  More Information

Responsible Party: Sheila Rauch, Clinical Director of Wounded Warrior Project and Associate Professor at Emory University, Principal Investigator, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT01524133     History of Changes
Other Study ID Numbers: PROGrESS 
Study First Received: January 27, 2012
Last Updated: June 16, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by VA Ann Arbor Healthcare System:
combat-related PTSD
Posttraumatic stress disorder
prolonged exposure therapy
sertraline
military
veterans
VA hospital
mental illness

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016