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 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT06215261
Eligibility Criteria:
Inclusion Criteria:
* Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
* Tried at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
* Proficient in reading and writing in local language sufficient to complete questionnaires.
* Free from any other clinically significant illness or disease.
Exclusion Criteria:
* Primary diagnosis of any other DSM-5 disorder.
* Body mass index (BMI) \<18kg/m2 or ≥40 kg/m2.
* Smokes an average of \>10 cigarettes and/or e-cigarettes per day.
* Uncontrolled hypertension at Screening.
* Use of prohibited concomitant medications or therapies.
* Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06215261
Study Brief:
Protocol Section:
NCT06215261