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

NCT05157945 | Completed Phase 2 FDA Drug

• 1 other identifier: ALTO-300-004
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (5)

• 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 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)

• 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)]

Study Arms (1)

ALTO-300

EXPERIMENTAL

ALTO-300 tablet PO; daily dosing 8 weeks

Drug: ALTO-300 PO Tablet

Interventions

ALTO-300 PO Tablet DRUG

One tablet daily

ALTO-300

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alto Neuroscience: lead

Study Sites (4)

Cerebral - Atlanta

Atlanta, Georgia, 30324, United States

Location

Site 171

Jackson, Mississippi, 39216, United States

Location

Cerebral - New York City

New York, New York, 10013, United States

Location

Cerebral - Dallas

Dallas, Texas, 75212, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: February 3, 2022
• Primary Completion: April 26, 2023
• Study Completion: May 5, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

US (4)