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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT03899194
Eligibility Criteria:
Inclusion Criteria for patients:
1. Drug-naive or medication free for no less than 4 weeks;
2. 18-60 years old, Han nationality;
3. Junior high school diploma or above;
4. Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR;
5. Scored 17 or higher on the Hamilton's Depression Scale with 17 items (HAMD-17) and scored 2 or higher for the 2nd item (depressive mood);
6. Written informed consent has been obtained.
Exclusion Criteria for patients:
1. Concurring psychotic disorders;
2. Woman who is pregnant or breast feeding or is planning to get pregnant;
3. Scores 3 or higher on item 3 (suicidal) of HAMD-17;
4. serious allergy or disease of immune system;
5. had anti-inflammatory drug or immunosuppressant in the past 1 month;
6. serious medical or surgical illness or history;
7. had MECT in the past 1 month.
Eligibility Criteria for healthy volunteers:
1. match the patient group in age, gender, education and handedness;
2. no history of psychiatric disorders or debilitating general medical disorders.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03899194
Study Brief:
Protocol Section:
NCT03899194