Posttraumatic Stress Disorder | PROlonGed ExpoSure Sertraline
Posttraumatic Stress Disorder research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Posttraumatic Stress Disorder
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:SertralineInitial 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 Therapyup to 13 sessions of prolonged exposure
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Sertraline + enhanced medication management (SERT/EMM)24 weeks of sertraline + enhanced medication management
Prolonged Exposure + sertraline (PE/SERT)Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
Prolonged Exposure + placebo (PE/PLB)Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Start Date: November 2011
Completed Date: May 2017
Phase: Phase 4
Primary Outcome: Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Secondary Outcome: Patient Health Questionnaire-15
Study sponsors, principal investigator, and references
Principal Investigator: Sheila Rauch, PhD
Lead Sponsor: VA Ann Arbor Healthcare System
Collaborator: U.S. Army Medical Research and Materiel Command