Pilot Decentralized Trial

NCT05419869 | Completed Phase 2 FDA Drug

• 1 other identifier: ALTO-100-003
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-100.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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)

• 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)

Study Arms (1)

ALTO-100

EXPERIMENTAL

ALTO-100 tablet PO ; twice daily dosing 8 weeks

Drug: ALTO-100 PO Tablet

Interventions

ALTO-100 PO Tablet DRUG

Two tablets daily

ALTO-100

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alto Neuroscience: lead

Study Sites (2)

Site 160

Coral Gables, Florida, 33134, United States

Location

Site 156

Jackson, Mississippi, 39216, 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: May 16, 2022
• First Posted: June 15, 2022
• Study Start: June 1, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 26, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (2)