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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT07104851
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a major depressive episode according to DSM-5 criteria, confirmed by two independent psychiatrists.
* First episode, with a duration of 4 weeks to 12 months.
* Age between 13 and 18 years.
* HAMD-17 score ≥ 17.
* Capable of normal communication.
* Provision of informed consent by both the adolescent and legal guardians.
Exclusion Criteria:
* Lifetime diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
* Depression secondary to a general medical condition or substance use.
* Acute suicidal risk (score ≥ 4 on MADRS item 10) requiring immediate intensive care.
* Currently receiving structured psychotherapy.
* Severe neurological or physical illness that could interfere with participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT07104851
Study Brief:
Protocol Section:
NCT07104851