ALTO-300 in Depression
Study Details
Study Description
Brief Summary
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: ALTO-300 ALTO-300 tablet PO; daily dosing 8 weeks |
Drug: ALTO-300 PO tablet
One tablet daily
|
Outcome Measures
Primary Outcome Measures
- To understand the relationship between baseline biology and clinical outcome with ALTO-300 using the Montgomery-Åsberg Depression Rating Scale (MADRS) [Measured 6 times over 8 weeks]
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.
- To understand the relationship between baseline biology and clinical outcome with ALTO-300 using the Clinical Global Impression scale - Severity (CGI-S) [Measured 6 times over 8 weeks]
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.
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-300 [From the signing of the ICF until the follow-up visit (up to 12 weeks)]
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.
- Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-300 [From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)]
Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.
- Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-300 [From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)]
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have a diagnosis of moderate to severe major depressive disorder
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Currently taking a SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
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Must have failed to adequately respond to the current antidepressant medication
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Willing to comply with all study assessments and procedures
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Must not be pregnant or breastfeeding at time of enrollment or throughout study
Exclusion Criteria:
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Evidence of liver impairment or disease
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Active suicidal ideation
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Moderate to severe Alcohol Use Disorder
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Diagnosed bipolar disorder or psychotic disorder
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Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients
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Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Site 102 | Dallas | Texas | United States | 75235 |
Sponsors and Collaborators
- Alto Neuroscience
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALTO-300-002