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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT04528628
Eligibility Criteria:
Inclusion Criteria:
1. 18-60 years old;
2. Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
3. Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
4. With enough audio-visual ability and comprehensive ability to accomplish the visits;
5. No medication or washout period of at least 2 weeks
6. Scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
Exclusion Criteria:
1. Existing serious and active physical diseases that may interfere with treatment (abnormal indicators\> 2 times the normal value), or there is a pharmacological conflict between the current medical medication and the study drug;
2. Previous mania or hypomania episodes;
3. Female patients who are pregnant, planning to be pregnant or breastfeeding;
4. Current high suicide risk (e.g. 3rd item of HAMD-24 scored≥3(suicidality));
5. Had ECT, MECT or rTMS in the past 6 months;
6. Experienced a history of dependence on psychoactive substances, organic mental disorders, personality disorders, mental retardation, neurodegenerative diseases, brain trauma and cerebrovascular diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04528628
Study Brief:
Protocol Section:
NCT04528628