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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT07047534
Eligibility Criteria:
Inclusion Criteria:
* Age 12-18 years;
* Diagnosis of major depressive disorder (MDD) according to the International Classification of Diseases, 10th Revision (ICD-10 F32);
* Documented self-harm behavior within 2 weeks prior to enrollment (defined as deliberate self-injury without suicidal intent, e.g., cutting, burning);
* Hamilton Depression Rating Scale (HAMD-24) score ≥17 at baseline;
* Ability to complete self-report measures and participate in group therapy.
Exclusion Criteria:
* Comorbid psychotic disorders (e.g., schizophrenia), bipolar disorder, or autism spectrum disorder;
* History of neurological conditions (e.g., epilepsy, traumatic brain injury);
* Current use of electroconvulsive therapy;
* Refusal to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT07047534
Study Brief:
Protocol Section:
NCT07047534