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 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT04597450
Eligibility Criteria:
Inclusion Criteria:
* The participant has PTSD, diagnosed according to Diagnostic and Statistical Manual Diploma in Social Medicine-5 (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).
* The participant has a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score ≥28 at screening and baseline.
* The participant has alterations in arousal and reactivity, confirmed on CAPS-5.
* The participant has ongoing sleep disturbances, confirmed on CAPS-5.
* The participant is willing to discontinue all prohibited medications during the study and to complete a washout of psychotropic medication during the washout period.
* The participant does not have any magnetic resonance imaging (MRI) contraindications.
Exclusion Criteria:
* The index traumatic event that led to development of PTSD took place \>15 years or \<6 months before screening.
Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04597450
Study Brief:
Protocol Section:
NCT04597450