Study of ALTO-300 in MDD

Launched by ALTO NEUROSCIENCE · Jun 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ALTO-300 for people with moderate to severe major depressive disorder (MDD). The goal is to find out how effective ALTO-300 is compared to a placebo (a non-active treatment) when used alongside a regular antidepressant. If you or someone you know has been diagnosed with MDD and is currently taking a specific type of antidepressant for at least six weeks, you might be eligible to participate in this study.

To join, participants must be aged between 18 and 75 years and should not be pregnant or breastfeeding. They should also be willing to follow the study guidelines. However, people with certain conditions, like unstable medical issues, bipolar disorder, or those using sleep medications every night, cannot take part. Those who join will have regular check-ins to assess their progress and how they respond to the treatment. This study is currently recruiting participants, so if you think you might be interested, it could be a great opportunity to help advance treatment for depression.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a diagnosis of moderate to severe major depressive disorder (MDD)
• • At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2
• • 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
• • 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