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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT05617495
Eligibility Criteria:
Inclusion Criteria:
* Ages 13-18 years-old
* Written informed assent/consent and parental/guardian permission for 13-17 year-olds or informed consent for 18 year-olds
* Tanner puberty stage ≥3
* Meets current diagnostic criteria for MDD
* English fluency
Exclusion Criteria:
* Lifetime history of primary psychotic disorders, bipolar disorder, oppositional defiant disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or eating disorders
* Substance use disorder, moderate or severe in past 6 months
* Active suicidal ideation with a specific plan
* History of seizure disorder
* Medical or neurological illness (e.g., severe head injury)
* MRI contraindications
* Current psychotropic medication use other than antidepressant medication
* Intelligence quotient (IQ) \<80.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT05617495
Study Brief:
Protocol Section:
NCT05617495