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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT03315793
Eligibility Criteria:
Inclusion Criteria:
* Participants diagnosed with Major Depressive Disorder or persistent depressive disorder and completely meet the criteria of major depressive episode as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) ver.7.0.2.
* Participants whose incipient age of depression was ≥7 years old.
* Total score of CDRS-R is ≥40 and CGI-S score is ≥4 at both screening and baseline.
Exclusion Criteria:
* Have remarkable response to psycho-education (defined as \>30% decrease in the total score of CDRS-R between screening and baseline).
* Have a current or previous diagnosis (DSM-5) of the following as judged by the investigator:
* Neurodevelopmental disorders
* Schizophrenia spectrum and other psychotic disorders
* Bipolar and related disorders
* Trauma and stressor-related disorders
* Disruptive · Impulse Control · and Conduct disorders
* Have a current diagnosis (DSM-5) of the following as judged by the investigator:
* Obsessive-compulsive and related disorders
* Anorexia nervosa, Bulimia nervosa, Binge-eating disorder
* Sleep-wake disorders
* Neurocognitive disorders
* Disruptive mood dysregulation disorder
* Have personality disorders, in the judgement of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
17 Years
Study:
NCT03315793
Study Brief:
Protocol Section:
NCT03315793