Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT01524133
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01524133
Study Brief:
Protocol Section:
NCT01524133