PD, PK, and Safety of ALTO-203 in Patients With MDD

Launched by ALTO NEUROSCIENCE · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ALTO-203 to see how it affects people with Major Depressive Disorder (MDD), particularly those experiencing symptoms like lack of pleasure or interest, known as anhedonia. The trial will involve two parts: first, participants will receive either ALTO-203 or a placebo (a substance with no active medication) in a single dose to see how they respond. Then, in the second part, participants will take ALTO-203 or a placebo daily for 28 days. Throughout the study, participants will complete questionnaires about their feelings and perform tasks to help assess their mental function, while the safety of the medication will be closely monitored.

To be eligible for this trial, participants should have moderate MDD and experience anhedonia, but they should not be taking any antidepressants at the start of the study. The trial is open to individuals aged 18 and older, regardless of gender. It's important to note that people with certain medical conditions, other specific mental health disorders, or those currently taking certain medications may not qualify. If you're interested in participating, you'll be asked to follow specific guidelines for the assessments and procedures involved in the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a diagnosis of moderate major depressive disorder (MDD)
• • Presence of anhedonia symptoms
• • Not taking antidepressant at Screening Visit 2
• • Willing to comply with all study assessments and procedures
• Exclusion Criteria:
• • Evidence of unstable medical condition
• • Diagnosed bipolar disorder, psychotic disorder, or dementia
• • Concurrent use of prohibited medications
• • Current moderate or severe substance use disorder
• • Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device