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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT05889234
Eligibility Criteria:
Inclusion criteria for the modified electroconvulsive therapy (MECT) and non-modified electroconvulsive therapy (Non-MECT) groups:
1. Age 13-18 years.
2. Meeting a diagnosis of depression (MDD) from the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) based the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
3. A score of ≥40 on the Childhood Depression Rating Scale-Revised (CDRS-R).
4. Adequate audiovisual level to be able to complete this study.
5. Signed informed consent and signed by the subject and guardian.
Healthy control group inclusion criteria.
1. Age 13-18 years.
2. Sufficient audio-visual level to be able to complete the study.
3. Signed informed consent form and signed by the subject and guardian.
Exclusion criteria for the modified electroconvulsive therapy (MECT) and non-modified electroconvulsive therapy (Non-MECT) groups:
1. The presence or previous presence of a serious medical, neurological or psychiatric condition (except in patients with MDD; anxiety co-morbidity is not considered an exclusion criterion, provided that MDD is the primary diagnosis and the main reason for seeking life-saving treatment).
2. Patients who have received electroconvulsive therapy within the last 12 months.
3. Patients with a history of substance, drug abuse.
4. Contraindications to anaesthesia or MRI.
5. Lactating women or pregnant women.
6. Left-handedness.
Exclusion criteria for healthy controls:
1. Presence or previous serious medical, neurological or psychiatric illness.
2. Patients with a history of substance or drug abuse.
3. Contraindications to MRI.
4. Lactating women or pregnant women.
5. Left-handedness.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT05889234
Study Brief:
Protocol Section:
NCT05889234