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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07412756
Eligibility Criteria:
Inclusion Criteria:
* Meet the diagnostic criteria for major depressive disorder
* Are on a stable standard of care medication for major depressive disorder
* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as
* self-inject study intervention
* store and use the provided blinded study intervention, as directed
* maintain electronic and paper study diaries, as applicable, and
* complete the required questionnaires
Exclusion Criteria:
* Have a lifetime history or current diagnosis of the following:
* schizophrenia or other psychotic disorder
* bipolar disorder
* borderline personality disorder, or
* any eating disorder.
* Have type 1 diabetes mellitus, or a history of
* ketoacidosis, or
* hyperosmolar state or coma.
* Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
* Are actively suicidal or deemed a significant risk for suicide
* Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07412756
Study Brief:
Protocol Section:
NCT07412756