Skip to main content
OpenTrials
Completed

NCT Number: NCT05419869

Pilot Decentralized Trial

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 160, Coral Gables, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALTO-100 PO Tablet

Drug

Two tablets daily

Primary outcomes

  1. 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

    Time frame: Measured at Day 1, Day 14, Day 28, Day 42, Day 56

    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.

  2. 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

    Time frame: Measured at Screening, Day 1, Day 14, Day 28, Day 42, Day 56

    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.

  3. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100

    Time frame: From the signing of the ICF until the follow-up visit (up to 13 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 Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100

    Time frame: From the signing of the ICF until the end-of-treatment visit (up to 13 weeks)

    Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.

Sponsors and collaborators

Lead sponsor

Alto Neuroscience

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2022
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.