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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT06618118
Eligibility Criteria:
Inclusion Criteria:
* Body mass index of 18 to 33 kg/m2 at the time of consent.
* Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for MDD based on the Structured Clinical Interview for DSM-5.
* Current major depressive episode of at least 6 weeks to less than 24 months in duration at Screening (Visit 1 ).
* Meets the following disease activity criteria mentioned in the protocol.
* Requires antidepressant therapy (ADT) per the investigator's opinion or, if currently taking ADT, must be able to safely discontinue ADT at least 7 days prior to the first dose of study drug at Baseline (Visit 2).
Exclusion Criteria:
\- Primary psychiatric illness other than MDD.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT06618118
Study Brief:
Protocol Section:
NCT06618118