Phase 4
Completed N=207
PROlonGed ExpoSure Sertraline
Source: ClinicalTrials.gov NCT01524133 ↗Enrolled (actual)
207
Serious AEs
3.9%
Results posted
Feb 2018
Primary outcomePrimary: 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
◆ Published Evidence
Established
40citations · ~7 / year
Associations between resting-state functional connectivity and treatment response in a randomized clinical trial for posttraumatic stress disorder.
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.
Linked Publications (5)
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Associations between resting-state functional connectivity and treatment response in a randomized clinical trial for posttraumatic stress disorder.
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Cortisol awakening response in PTSD treatment: Predictor or mechanism of change.
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Neural function during emotion processing and modulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder.
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Predictors of Response to Prolonged Exposure, Sertraline, and Their Combination for the Treatment of Military PTSD.
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Reductions in guilt cognitions following prolonged exposure and/or sertraline predict subsequent improvements in PTSD and depression.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT01524133) and the linked publication. 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. Informational only — not medical advice.