Phase 2b Study of ALTO-100 in MDD
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of moderate to severe major depressive disorder (MDD) At baseline, either not taking an antidepressant medication, or currently taking a single 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 medical condition 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
ALTO-100
Placebo DB
Participants will receive ALTO-100 tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open label (OL) treatment period will receive ALTO-100 tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).
Participants will receive matching placebo tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period.