Phase 4 N=207 Randomized Double-blind Treatment

PROlonGed ExpoSure Sertraline

Posttraumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01524133 ↗

Enrolled (actual)

207

Serious AEs

3.9%

Results posted

Feb 2018

Primary outcome: Primary: Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) — 41.7; 43.3; 51.5 Scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sertraline (Drug); Prolonged Exposure Therapy (Behavioral)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: VA Ann Arbor Healthcare System
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)	41.7; 43.3; 51.5	—
SECONDARY Patient Health Questionnaire-15	8.6; 9.8; 10.5	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01524133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.