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:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT05597566
Eligibility Criteria:
Inclusion Criteria:
Provide written informed consent; Age 60 to 85 years old, including 60 and 85 years old;
Meet the diagnostic criteria for single or recurrent major depressive disorder in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition);
Currently in the acute phase, with a total score of 17-item Hamilton Depression Rating Scale (HDRS-17) ≥ 24 at baseline;
History of suicide attempt in this depressive episode; Rating Scale (SIOSS)≥12 points;
Exclusion Criteria:
Patients with a history of epilepsy or coronary heart disease or other serious unstable physical diseases;
Patients with acute inflammatory infection or chronic inflammatory disease; Patients in the past 1 month Participated in another interventional clinical study;
Past or current diagnosis of the following psychiatric diseases by DSM-IV: organic mental disorder, Alzheimer's disease, secondary dementia due to other causes, mental illness Schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder, unspecified mental illness, and patients with a history of drug abuse, including alcohol and active drug abuse in the past 12 months, except for nicotine;
Severe aphasia , visual and hearing impairment, etc. who cannot complete the scale evaluation;
Those who have contraindications to MECT treatment;
Those who are pregnant, lactating women or planning to become pregnant; Those who are allergic to atropine, propofol, and succinylcholine chloride.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT05597566
Study Brief:
Protocol Section:
NCT05597566