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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT06372834
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged 20-65 years, met criteria for DSM-V major depressive disorder.
* A depression severity score of 18 or more on the 17-item Hamilton Rating Scale for Depression (HRSD-17) as well as a score of 1 or more on the item of the HDRS-17 (item 3).
* Meeting criteria for TRD defined as no clinical response to at least one adequate trial of one major class of antidepressants.
* Having been receiving stable antidepressant medications regimen for more than 4 weeks before enrollment and having their original medication regimen unchanged throughout the trial.
Exclusion Criteria:
* Having MDD with psychotic features, bipolar disorder, schizophrenia, organic brain syndrome or active substance (except for tobacco and coffeine) use disorder.
* Having previous intracranial surgery and ferromagnetic metallic implants in the head.
* History of brain abnormalities (e.g., brain neoplasms, arteriovenous malformations, meningitis, encephalitis, epilepsy, neurodegenerative disorders).
* Pregnancy at enrollment.
* History of treatment with electroconvulsive therapy (ECT) or no response to rTMS over the left DLPFC.
* Those who had attempted a suicide within six months from the screening date.
* Skin lesions on scalp at the area of coil application.
* In addition to those listed above, those who were deemed unsuitable for participating in this clinical trial by the medical judgment of the investigator due to other reasons (e.g., lack of competence to consent to research or any other contraindications to receiving rTMS).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT06372834
Study Brief:
Protocol Section:
NCT06372834