Pilot Decentralized Trial

Major Depressive Disorder Clinical Trial

Official title:

An Open-Label Study of ALTO-100 in Adults With Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05419869
• Other study ID #: ALTO-100-003
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: January 26, 2023

Study information

• Verified date: January 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-100.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 26, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Have a diagnosis of moderate to severe major depressive disorder

• Either currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication

• Willing to comply with all study assessments and procedures

• Must not be pregnant or breastfeeding at time of enrollment or throughout study

• Must have access with privacy to a computer with a keyboard and internet

Exclusion Criteria:

• Evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease

• Active suicidal ideation

• Severe impediment to vision, hearing, and/or hand movement

• Diagnosed bipolar disorder or psychotic disorder

• Has a history of hypersensitivity or allergic reaction to ALTO-100 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-100 PO Tablet
Two tablets daily

Locations

Country	Name	City	State
United States	Site 160	Coral Gables	Florida
United States	Site 156	Jackson	Mississippi

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 score change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-100 from start of dosing to end of treatment	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 score change from the start of dosing (Day 1) to the end of treatment (Day 56) is the primary outcome.	Measured at Day 1, Day 14, Day 28, Day 42, Day 56
Primary	To understand the relationship between baseline biology and score change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-100 from Screening to end of treatment	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 score change from Screening (Day [-21]) to the end of treatment (Day 56) is the primary outcome.	Measured at Screening, Day 1, Day 14, Day 28, Day 42, Day 56
Primary	Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100	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 13 weeks)
Primary	Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100	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 13 weeks)

External Links

•   Alto Neuroscience Mental Health Research Registry