ALTO-300 in Depression (ALTO-300-004)

Study Overview
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Brief Summary
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The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.

Official Title
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AN OPEN-LABEL STUDY OF ALTO-300 IN ADULTS WITH MAJOR DEPRESSIVE DISORDER

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: ALTO-300 PO Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of moderate to severe major depressive disorder Currently taking a SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks Must have failed to adequately respond to the current antidepressant medication 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 liver impairment or disease Active suicidal ideation Moderate to severe Alcohol Use Disorder Diagnosed bipolar disorder or psychotic 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALTO-300<br>ALTO-300 tablet PO; daily dosing 8 weeks | Drug: ALTO-300 PO Tablet<br>* One tablet daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To understand the relationship between baseline biology and change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-300 | The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. The change from baseline to the end of the study is the primary outcome. | Measured 6 times over 8 weeks | 
| To understand the relationship between baseline biology and change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-300 | The Clinical Global Impression scale - Severity (CGI-S) measures the severity of psychopathology in general where smaller scores indicate less illness and higher scores suggest more severe illness. Possible scores for this scale range from 1 to 7. The change from baseline to the end of the study is the primary outcome. | Measured 6 times over 8 weeks | 
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-300 | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | From the signing of the ICF until the follow-up visit (up to 12 weeks) | 
| Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-300 | Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight. | From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)] | 
| Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-300 | Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing. | From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)] |