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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT05117632
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of moderate to severe major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD)
* At baseline, either not taking an antidepressant medication, or currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
* Willing to comply with all study assessments and procedures
* Must not be pregnant or breastfeeding at time of enrollment or throughout study
Exclusion Criteria:
* Evidence of unstable cardiovascular, respiratory, liver, or renal impairment or disease
* Active suicidal ideation
* Diagnosed bipolar disorder, psychotic disorder, or dementia
* Current moderate or severe substance use disorder
* Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT05117632
Study Brief:
Protocol Section:
NCT05117632