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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05157945
• Other study ID #: ALTO-300-004
• Status: Completed
• Phase: Phase 2
• Start date: February 3, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: April 2024
• Source: Alto Neuroscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 5, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• ALTO-300 PO Tablet
One tablet daily

Locations

Country	Name	City	State
United States	Cerebral - Atlanta	Atlanta	Georgia
United States	Cerebral - Dallas	Dallas	Texas
United States	Site 171	Jackson	Mississippi
United States	Cerebral - New York City	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alto Neuroscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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)]
Primary	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)]