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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT05950061
Eligibility Criteria:
Inclusion Criteria:
* Eligible participants had to have a score of at least 20 on the MADRS at both screening and baseline visits.
* All participants who had moderate or severe depression
* Study participants had to have normal results on physical examination, laboratory tests, and electrocardiograms, or any abnormalities had to be clinically insignificant.
* Female participants of childbearing potential had to have a negative pregnancy test and be using medically approved contraception.
Exclusion Criteria:
* Lactating women were not eligible to participate.
* Individuals with a psychiatric disorder other than MDD
* Individuals with a history of any Diagnostic and Statistical Manual -V defined psychotic disorder
* Individuals with current diagnosis of bipolar disorder
* Individuals with current diagnosis of schizophrenia
* Individuals with current diagnosis of obsessive-compulsive disorder
* Individuals with intellectual disability
* Individuals with a pervasive development disorder.
* Participants with current substance abuse or dependency,
* Participants with suicidal risk,
* Participants with personality disorders that would impede participation in study
* Participants were also not eligible to participate if they had used a selective serotonin release inhibitor (SSRI) in the past two weeks (past five weeks if they used fluoxetine).
* Participants with Montgomery-Åsberg Depression Rating Scale score of \<19.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT05950061
Study Brief:
Protocol Section:
NCT05950061