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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT05588102
Eligibility Criteria:
Inclusion Criteria:
1. The patients and their family members signed the written informed consent
2. Age ≥60 years old
3. Meet the diagnostic criteria for single or recurrent major depressive disorder in the diagnostic and Statistical Manual of mental disorders Fourth Edition (DSM-V)
4. Currently in the acute phase, HAMD-17 total score at baseline ≥ 18 points
5. There are symptoms of cognitive impairment, Montreal Cognitive Assessment scale (Montreal Cognitive Assessment scale, MoCA) \<26 points
6. Education level above primary school.
Exclusion Criteria:
1. Patients with history of epilepsy or coronary heart disease or other serious unstable physical diseases
2. Participated in another intervention clinical study in the past 1 month
3. The following mental diseases have been or are currently diagnosed by DSM-V: organic mental disorder, Alzheimer's disease, secondary dementia caused by other causes, schizophrenia, schizophrenic affective disorder, bipolar disorder, delusional disorder, undefined mental disease, patients with drug abuse history, including alcohol and active drug abuse in the past 12 months, except nicotine
4. He has been taking antidepressants, mental retardants and other psychiatric drugs for the past 2 weeks
5. Severe aphasia, visual and hearing impairment, etc. unable to complete the scale evaluation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT05588102
Study Brief:
Protocol Section:
NCT05588102