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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03369418
Eligibility Criteria:
Inclusion Criteria:
1. Male
2. Within the age range of 18-40 years old
3. Score 8-14 on either the anxiety or depression HADS scale as defined as mild (8-10) to moderate (11-14)
4. Subjects who receive anxiety, depression, psychiatric or mental health treatment (pharmacological or non-pharmacological) must be on a stable regimen for the past 3 months
5. No active suicidal ideation or psychosis (including schizophrenia and bipolar disorder)
6. No uncontrolled or progressive severe medical illness (e.g., cancer, uncontrolled diabetes mellitus, active cardiac disease)
7. No use of a pacemaker or any other implanted electrical device
8. No alcohol consumption greater than 2 units daily
9. Ability to independently complete the in-person study questionnaires and sign informed consent form (ICF) without assistance
10. Willing to comply with all study procedures and be available for the duration of the study
11. No participation in another clinical trial study
Exclusion Criteria:
1. Not a male
2. Younger than 18 years old or older than 40 years old
3. Score ≥15 on either the anxiety or depression HADS scale as defined as severe (15-20)
4. Subject who receive anxiety, depression, psychiatric or mental health treatment (pharmacological or non-pharmacological) who have not been on a stable regimen for the past 3 months
5. Active suicidal ideation or psychosis (including schizophrenia and bipolar disorder)
6. History of inpatient treatment or suicidal ideation within the last year
7. Use of a pacemaker or any other implanted electrical device
8. Unable to independently complete the in-person study questionnaires and sign ICF due to impaired cognitive function
9. Unwilling to comply with all study procedures
10. Unavailable for the duration of the study
11. Current participation in another clinical trial study
12. Any other condition that the investigator believes would jeopardize the safety or rights of the subject or would render the subject unable to comply with the study protocol or make use of acquired data non-analyzable
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03369418
Study Brief:
Protocol Section:
NCT03369418