RECRUITING

Study of ALTO-300 in MDD

Description

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

Major Depressive Disorder
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Related Conditions:

Major Depressive Disorder

Study Overview

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Study Details

Study overview

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

A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder

Study of ALTO-300 in MDD

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Phoenix

Site 200, Phoenix, Arizona, United States, 85012

Phoenix

Site 189, Phoenix, Arizona, United States, 85021

Yuma

Site 187, Yuma, Arizona, United States, 85364

Rogers

Site 193, Rogers, Arkansas, United States, 72758

Bellflower

Site 218, Bellflower, California, United States, 90706

Glendale

Site 217, Glendale, California, United States, 91206

Lafayette

Site 335, Lafayette, California, United States, 94549

Los Angeles

Site 209, Los Angeles, California, United States, 90064

Mather

Site 219, Mather, California, United States, 95655

Mission Viejo

Site 194, Mission Viejo, California, United States, 92691

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have a diagnosis of moderate to severe major depressive disorder (MDD)
  • * At Visit 2, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
  • * Willing to comply with all study assessments and procedures
  • * Must not be pregnant or breastfeeding at time of enrollment or throughout study
  • * Evidence of unstable medical condition
  • * Nightly use of sleep medication
  • * Diagnosed bipolar disorder, psychotic disorder, or dementia
  • * Current moderate or severe substance use disorder
  • * Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients
  • * Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alto Neuroscience,

Adam Savitz, MD, PhD, STUDY_DIRECTOR, Alto Neuroscience

Study Record Dates

2025-05