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 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT05300204
Eligibility Criteria:
Inclusion Criteria:
* The presence of a current or remitted diagnosis of a mild, moderate, or severe major depressive episode according to ICD-10 Criteria: F32.0; F32.1; F32.2, F33.0, F33.1, F.33.2) is assessed using a semi structured clinical Interview: the "Kinder-DIPS". The Kinder-DIPS is a well-established German interview for the diagnosis of a wide range of axis I psychiatric disorders in children from ages six to 18.
* Depressive symptomatology is measured as well with the Beck Depression Inventory Second Edition (BDI-II) for descriptive purposes. The BDI-II is a self-report inventory to assess the severity of depressive symptoms, rated on a 4-point response scale, with higher scores indicating more severe depressive symptoms.
* Intelligence quotient (IQ) of ≥ 80.
Exclusion Criteria:
* Acute suicidality
* Schizophrenic disorder
* Pervasive developmental disorder
* Bipolar disorder
* Borderline personality disorder
* Substance dependence disorder
* Insufficient knowledge of German
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT05300204
Study Brief:
Protocol Section:
NCT05300204