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 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT07226661
Eligibility Criteria:
Inclusion Criteria:
* Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI
* Duration of current MDE of at least 8 weeks
* MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit
* CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit and Day 1 Visit
* Stable, therapeutic dose of one of the following protocol-approved ADTs as a monotherapy for ≥ 8 weeks before the Screening Visit and ≥ 10 weeks at the Day 1 Visit. Additionally, inadequate response to the current ADT (less than 50% improvement in depressive symptoms) as confirmed by the ATRQ Investigator administered.
Exclusion Criteria:
* MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit
* History of treatment resistant depression (TRD) defined as 3 or more failed ADTs of adequate dose (per ATRQ) and duration (at least 8 weeks) for the current MDE
* History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit
* Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion
* Lifetime diagnosis of any psychotic disorder including MDD with psychosis, MDD with mixed features, bipolar I/II disorder, bipolar depression, schizophrenia, posttraumatic stress disorder, autism spectrum disorder, or any personality disorder or intellectual disability that would affect the ability of the participant to enroll in the study
* Diagnosis less then 12 months before screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or any other psychiatric condition that has been the primary focus of treatment, or diagnosis of generalized anxiety disorder less then 6 months before screening.
* History of cardiovascular, respiratory, gastrointestinal, renal, hepatic, and hematologic disorders, or other medical disorders that could impose undue risk or compromise the study in the Investigator's opinion
* Clinically significant abnormal result prior to Day 1 Visit per Investigator's judgment or abnormal renal function.
* Requires treatment with a medication or other substance that is prohibited by the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07226661
Study Brief:
Protocol Section:
NCT07226661