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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT06973759
Eligibility Criteria:
Inclusion Criteria:
1. Chinese, aged 12-19 years old;
2. Written informed assent/consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18), respectively;
3. Having a DSM-5 diagnosis of unipolar non-seasonal depression as confirmed by the Chinese version of the Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS) psychiatric interview, DSM-5 Seasonal specifier, AND having a score on Children's Depression Rating Scale (CDRS-R) at least 40;
4. Being classified as evening chronotype according to the score on the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ), i.e. \<12.
Exclusion Criteria:
1. A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, organic mental disorders, or intellectual disabilities;
2. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by K-SADS;
3. Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
4. Initiation of or change in antidepressant medication within past 4 weeks;
5. Having been or is currently receiving any structured psychotherapy;
6. With hearing or speech deficit;
7. Night shift worker;
8. Trans-meridian flight across at least two time zones in the past 3 months and during the study;
9. Presence of an eye disease, e.g., retinal blindness, severe cataract, glaucoma.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
19 Years
Study:
NCT06973759
Study Brief:
Protocol Section:
NCT06973759