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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT04637620
Eligibility Criteria:
Inclusion Criteria:
* Have a DSM-5 (American Psychiatric Association) diagnosis of MDD
* 17-item Hamilton Rating Scale for Depression total score ≥ 18
* Free of antidepressant drugs for at least 2 weeks
* Agree to participate in the study and provide informed consent
Exclusion Criteria:
* Current substance abuse or history of substance dependence in the past 6 months
* History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study
* Bipolar depression, schizophrenia or other psychotic disorder
* Moderate-severe suicidal risks
* Severe cognitive impairment
* Initiating or stopping formal psychotherapy within six weeks prior to enrollment
* A history of severe adverse reaction to SSRIs
* A treatment-resistant history (that is, they have failed to respond to two or more different classes of antidepressants with adequate dosage and treatment duration
* A history of previously received electroconvulsive therapy
* Inability to follow protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04637620
Study Brief:
Protocol Section:
NCT04637620