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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT07011693
Eligibility Criteria:
Inclusion Criteria:
1. Aged 12-17;
2. As assessed by K-SADS-PL, it meets the DSM-5 criteria for MDD;
3. CDRS-R≥45;
4. CGI-S≥4;
5. Failed to respond to an initial SSRI trial: the trial at least 8 weeks, with the last of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent.
Exclusion Criteria:
1. Current or lifetime diagnosis of bipolar disorder, schizophrenia, autism, attention-deficit/hyperactivity disorder or obsessive-compulsive disorder or psychosis not otherwise specified;
2. MDD with psychotic symptoms;
3. YMRS\>13;
4. Current or lifetime diagnosis of serious neurologic diseases such as epilepsy, brain trauma or other serious physical illnesses;
5. Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length (at least 8 weeks, with the last 4 of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent);
6. History of clear-cut intolerability of, or lack of effect with, an adequate trial of sertraline, agomelatine, or aripiprazole;
7. Current depressive episode with clear suicidal plans or behaviors;
8. Received modified electroconvulsive therapy within 3 months;
9. Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment;
10. Substance abuse or dependence;
11. Female patients with pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT07011693
Study Brief:
Protocol Section:
NCT07011693