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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT05555927
Eligibility Criteria:
Inclusion Criteria:
1. Ages are from 18 to 50;
2. Meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for current unipolar MDD, which is assessed by at least one professional psychiatrist;
3. Han ethnicity;
4. Right handedness;
5. With a score≥17 on the HAMD-1713;
6. With a score≥6 on the BSI14;
7. Without any pharmacotherapy at baseline or maintaining actual pharmacotherapy for at least 2 weeks before the stimulation initiation and during the total stimulation period.
Exclusion Criteria:
1. Assessed through applying the Mini-International Neuropsychiatric Interview (MINI)15 by professional psychiatrists that diagnosed any other current or past psychiatric axis-I disorders (except MDD in the patients);
2. Severe liver and kidney diseases, active endocrine diseases or clinical symptoms. Severe cardiovascular disease, respiratory system disease, haematologic diseases and cancer;
3. Any clinically significant abnormal laboratory examination that may influence the health of participants;
4. A history of any aignificant medical illness such as neurological disorders (such as cerebral trauma, seizure disorder, etc);
5. Known current psychosis as determined by the DSM-5 or a history of a non-mood psychotic disorder;
6. Current alcohol and drug abuse;
7. Pregnancy or lactation;
8. Abnormal scalp such as open wounds;
9. HAMD-17 item 3 (suicide) score=4;
10. Receiving modified electroconvulsive therapy (MECT) or repetitive transcranial magnetic stimulation (rTMS) in the past 1 month;
11. Participation in another clinical trial concurrently or no more than 1 month prior to randomisation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05555927
Study Brief:
Protocol Section:
NCT05555927