RecruitingPhase 2NCT05922878

Study of ALTO-300 in MDD

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

Sponsor

Alto Neuroscience

Enrollment

321 participants

Start Date

Jun 8, 2023

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ALTO-300 as an add-on treatment for people with moderate to severe depression (major depressive disorder, MDD) who are already taking a standard antidepressant but are not getting enough relief. ALTO-300 is being investigated for its potential to boost the effects of existing antidepressant medications. **You may be eligible if:** - You have been diagnosed with moderate to severe major depressive disorder (MDD) - You are currently taking a single antidepressant from the SSRI, SNRI, or bupropion class for at least 6 weeks, at a stable dose for the past 2 weeks - You are not pregnant or breastfeeding - You are willing and able to follow all study procedures and assessments **You may NOT be eligible if:** - You have an unstable or serious medical condition - You regularly take sleep medications at night - You have been diagnosed with bipolar disorder, a psychotic disorder, or dementia - You have moderate or severe substance use disorder - You have a known allergy to ALTO-300 or any of its components - You have recently participated in another clinical trial for a mental health condition using an experimental drug or device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALTO-300

ALTO-300 capsule QD

DRUGPlacebo

Placebo capsule QD

Locations(45)

Site 200

Phoenix, Arizona, United States

Site 189

Phoenix, Arizona, United States

Site 187

Yuma, Arizona, United States

Site 193

Rogers, Arkansas, United States

Site 218

Bellflower, California, United States

Site 217

Glendale, California, United States

Site 335

Lafayette, California, United States

Site 209

Los Angeles, California, United States

Site 219

Mather, California, United States

Site 194

Mission Viejo, California, United States

Site 197

Temecula, California, United States

Site 203

Colorado Springs, Colorado, United States

Site 349

Evergreen, Colorado, United States

Site 214

Norwalk, Connecticut, United States

Site 159

Clermont, Florida, United States

Site 225

Miami Gardens, Florida, United States

Site 190

Miami Lakes, Florida, United States

Site 161

Okeechobee, Florida, United States

Site 221

Tampa, Florida, United States

Site 220

West Palm Beach, Florida, United States

Site 224

Savannah, Georgia, United States

Site 208

Snellville, Georgia, United States

Site 119

Boise, Idaho, United States

Site 310

Chicago, Illinois, United States

Site 201

Marrero, Louisiana, United States

Site 198

Monroe, Louisiana, United States

Site 215

Jackson, Mississippi, United States

Site 344

Las Vegas, Nevada, United States

Site 114

Albuquerque, New Mexico, United States

Site 191

Rochester, New York, United States

Site 192

Staten Island, New York, United States

Site 199

Hickory, North Carolina, United States

Site 202

Cincinnati, Ohio, United States

Site 195

Oklahoma City, Oklahoma, United States

Site 216

Allentown, Pennsylvania, United States

Site 350

Media, Pennsylvania, United States

Site 352

Moosic, Pennsylvania, United States

Site 102

Dallas, Texas, United States

Site 347

Fort Worth, Texas, United States

Site 148

Fort Worth, Texas, United States

Site 206

Missouri City, Texas, United States

Site 353

Plano, Texas, United States

Site 196

Richmond, Texas, United States

Site 207

Clinton, Utah, United States

Site 211

Roanoke, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05922878

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Study of ALTO-300 in MDD

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(45)

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