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Study of ALTO-300 in MDD

NCT05922878 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2025-07-24

No results posted yet for this study

Summary

The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.

Conditions

Interventions

DRUG

ALTO-300

ALTO-300 capsule QD

DRUG

Placebo

Placebo capsule QD

Sponsors & Collaborators

  • Alto Neuroscience

    lead INDUSTRY

Principal Investigators

  • Adam Savitz, MD, PhD · Alto Neuroscience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05922878 on ClinicalTrials.gov