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:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01600456
Eligibility Criteria:
Inclusion Criteria:
* DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders) diagnosis of PTSD (with severity threshold)
* Experienced traumatic event at least 12 weeks prior to study entry
* Willingness to discontinue current CBT or antidepressant treatment if needed
Exclusion Criteria:
* Current diagnosis of schizophrenia or delusional disorder
* Medically unstable bipolar disorder, depression with psychotic features, or depression requiring immediate psychiatric treatment
* No clear trauma memory or trauma before age 3
* Current diagnosis of alcohol or substance dependence within 3 months prior to study entry
* Ongoing intimate relationship with the perpetrator of the traumatic event
* History of nonresponse to adequate trial of either CBT or sertraline
* Medical contraindication for sertraline
* Current high dose use of benzodiazepines
* Pregnant or sexually active female without adequate birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01600456
Study Brief:
Protocol Section:
NCT01600456