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

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

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: ALTO-300 PO Tablet

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jacob Randazzo; Phone Number: 6503975693; Email: clinical@altoneuroscience.com

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30324
      • Cerebral - Atlanta
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Site 171
  • New York
    • New York, New York, United States, 10013
      • Cerebral - New York City
  • Texas
    • Dallas, Texas, United States, 75212
      • Cerebral - Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 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)]

Collaborators and Investigators

• Sponsor: Alto Neuroscience

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: ALTO-300-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No