A Phase 2 interventional study of ALTO-300 PO Tablet in Major Depressive Disorder, sponsored by Alto Neuroscience. Completed at 4 sites in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Alto Neuroscience · Phase 2, Interventional, and Treatment
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's enrollment of 148 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Alto Neuroscience is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
ALTO-300 tablet PO; daily dosing 8 weeks
Drug: ALTO-300 PO Tablet
One tablet daily
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)]
Ran from Feb 2022 to primary completion in Apr 2023, 14 months.
Of 96 industry-sponsored phase 2 interventional studies under Depressive Disorder, Major, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 23. This study's 14 months is below that.
Counting every sponsor, half of 189 studies reached it within 22 months; a quarter within 14 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ALTO-300
Alto Neuroscience