ALTO-300

Summary

ALTO-300 is a 25 mg formulation of the atypical antidepressant agomelatine, which targets the melatonin and serotonin signaling systems and has been shown to modulate mood and circadian rhythms. This medication is approved for the treatment of depression in several countries outside of the United States. Like all antidepressants, ALTO-300 works better for some patients than others. Accordingly, establishing biological predictors may allow a better understanding of which patients may best respond to treatment with ALTO-300.

To be included in ALTO-300, participants must be / have

• Have a diagnosis of moderate to severe major depressive disorder (MDD)
• At visit two, currently taking a single SSRI, SNRI or bupropion for at least six weeks with no dose modifications in the past two weeks
• Willing to comply with all study assessments and procedures
• Must not be pregnant or breastfeeding at the time of enrollment or throughout the study

To be included in ALTO-300, participants must not be / have

• Evidence of unstable medical condition
• Nightly use of sleep medication
• Diagnosed bipolar disorder, psychotic disorder or dementia
• Current moderate or severe substance use disorder
• Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients
• Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device