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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT01965366
Eligibility Criteria:
Inclusion Criteria:
1. Participants will be 60 males and females between ages of 21 and 65.
2. Participants must meet DSM-V criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom and/or Operation Enduring Freedom-Afghanistan and Operation New Dawn.
3. Patients must be literate in English.
4. Patients must be medically healthy or medically stable such that the stress of VR and DEX are not contraindicated.
5. Participants must comprehend his or her role in the study and the risks involved in order to be entered.
Exclusion Criteria:
1. Patients with a history of mania, schizophrenia, or other psychoses;
2. Patients with prominent suicidal ideation;
3. Patients with current alcohol or drug dependence;
4. Patients unable to tolerate wearing the VR helmet;
5. Patients unwilling to take study medication;
6. Patients on psychotropic medication(s) must have been on a stable dose for at least 2 weeks prior to beginning the study and must agree not to change their current medication regimen throughout the course of the study. The concomitant use of psychotropic medications will be recorded and examined in data analyses.
7. Patients with special medical conditions such as pregnancy, renal insufficiency, or a history of significant head injury
8. Active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, SLE, advanced cirrhosis, etc. (per clinical judgment of study physician)
9. Patients stabilized on potentially data-obscuring medications (glucocorticoids).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01965366
Study Brief:
Protocol Section:
NCT01965366