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Phase 2b Study of ALTO-100 in MDD

NCT05712187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2025-09-08

No results posted yet for this study

Summary

The purpose of this study is to determine efficacy differences between ALTO-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.

Conditions

Interventions

DRUG

ALTO-100

ALTO-100 tablet BID

DRUG

Placebo

Placebo tablet BID

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
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2024-09-05
Completion
2024-10-24
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 NCT05712187 on ClinicalTrials.gov