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

• ClinicalTrials.gov Identifier: NCT05157945
• Recruitment Status: Completed
• First Posted: December 15, 2021
• Last Update Posted: April 26, 2024
• Sponsor: Alto Neuroscience
• Information provided by (Responsible Party): Alto Neuroscience

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
Major Depressive Disorder	Drug: ALTO-300 PO Tablet	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 148 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: AN OPEN-LABEL STUDY OF ALTO-300 IN ADULTS WITH MAJOR DEPRESSIVE DISORDER
• Actual Study Start Date: February 3, 2022
• Actual Primary Completion Date: April 26, 2023
• Actual Study Completion Date: May 5, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. To understand the relationship between baseline biology and change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-300 [ Time Frame: 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.
2. To understand the relationship between baseline biology and change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-300 [ Time Frame: 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.
3. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-300 [ Time Frame: 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.
4. Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-300 [ Time Frame: 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.
5. Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-300 [ Time Frame: 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

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

Criteria

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

Contacts and Locations

Locations

United States, Georgia

Cerebral - Atlanta

Atlanta, Georgia, United States, 30324

United States, Mississippi

Site 171

Jackson, Mississippi, United States, 39216

United States, New York

Cerebral - New York City

New York, New York, United States, 10013

United States, Texas

Cerebral - Dallas

Dallas, Texas, United States, 75212

Sponsors and Collaborators

Alto Neuroscience

More Information

• Responsible Party: Alto Neuroscience
• ClinicalTrials.gov Identifier: NCT05157945
• Other Study ID Numbers: ALTO-300-004
• First Posted: December 15, 2021
• Last Update Posted: April 26, 2024
• Last Verified: April 2024

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms