Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT05922878

Study of ALTO-300 in MDD

Led by Alto Neuroscience · Updated on 2025-07-24

321

Participants Needed

45

Research Sites

181 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Study of ALTO-300 in MDD

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a diagnosis of moderate to severe major depressive disorder (MDD)
  • Currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose changes in the past 2 weeks
  • Willing to comply with all study assessments and procedures
  • Not pregnant or breastfeeding at enrollment or during the study
Not Eligible

You will not qualify if you...

  • Evidence of unstable medical condition
  • Nightly use of sleep medication
  • Diagnosed bipolar disorder, psychotic disorder, or dementia
  • Current moderate or severe substance use disorder
  • History of hypersensitivity or allergic reaction to ALTO-300 or its components
  • Participation in another mental illness clinical trial with investigational products or devices recently or concurrently

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 45 locations

1

Site 200

Phoenix, Arizona, United States, 85012

Actively Recruiting

2

Site 189

Phoenix, Arizona, United States, 85021

Withdrawn

3

Site 187

Yuma, Arizona, United States, 85364

Actively Recruiting

4

Site 193

Rogers, Arkansas, United States, 72758

Actively Recruiting

5

Site 218

Bellflower, California, United States, 90706

Actively Recruiting

6

Site 217

Glendale, California, United States, 91206

Actively Recruiting

7

Site 335

Lafayette, California, United States, 94549

Actively Recruiting

8

Site 209

Los Angeles, California, United States, 90064

Actively Recruiting

9

Site 219

Mather, California, United States, 95655

Actively Recruiting

10

Site 194

Mission Viejo, California, United States, 92691

Actively Recruiting

11

Site 197

Temecula, California, United States, 92591

Actively Recruiting

12

Site 203

Colorado Springs, Colorado, United States, 80918

Actively Recruiting

13

Site 349

Evergreen, Colorado, United States, 80439

Actively Recruiting

14

Site 214

Norwalk, Connecticut, United States, 06851

Actively Recruiting

15

Site 159

Clermont, Florida, United States, 34711

Actively Recruiting

16

Site 225

Miami Gardens, Florida, United States, 33014

Actively Recruiting

17

Site 190

Miami Lakes, Florida, United States, 33016

Actively Recruiting

18

Site 161

Okeechobee, Florida, United States, 34972

Actively Recruiting

19

Site 221

Tampa, Florida, United States, 33629

Actively Recruiting

20

Site 220

West Palm Beach, Florida, United States, 33407

Actively Recruiting

21

Site 224

Savannah, Georgia, United States, 31405

Actively Recruiting

22

Site 208

Snellville, Georgia, United States, 30078

Actively Recruiting

23

Site 119

Boise, Idaho, United States, 83702

Actively Recruiting

24

Site 310

Chicago, Illinois, United States, 60634

Actively Recruiting

25

Site 201

Marrero, Louisiana, United States, 70072

Terminated

26

Site 198

Monroe, Louisiana, United States, 71201

Terminated

27

Site 215

Jackson, Mississippi, United States, 39216

Actively Recruiting

28

Site 344

Las Vegas, Nevada, United States, 89102

Actively Recruiting

29

Site 114

Albuquerque, New Mexico, United States, 87108

Actively Recruiting

30

Site 191

Rochester, New York, United States, 14618

Terminated

31

Site 192

Staten Island, New York, United States, 10314

Actively Recruiting

32

Site 199

Hickory, North Carolina, United States, 28601

Actively Recruiting

33

Site 202

Cincinnati, Ohio, United States, 45215

Actively Recruiting

34

Site 195

Oklahoma City, Oklahoma, United States, 73112

Actively Recruiting

35

Site 216

Allentown, Pennsylvania, United States, 18104

Actively Recruiting

36

Site 350

Media, Pennsylvania, United States, 19063

Actively Recruiting

37

Site 352

Moosic, Pennsylvania, United States, 18507

Actively Recruiting

38

Site 102

Dallas, Texas, United States, 75235

Withdrawn

39

Site 347

Fort Worth, Texas, United States, 76104

Actively Recruiting

40

Site 148

Fort Worth, Texas, United States, 76244

Withdrawn

41

Site 206

Missouri City, Texas, United States, 77459

Withdrawn

42

Site 353

Plano, Texas, United States, 75093

Not Yet Recruiting

43

Site 196

Richmond, Texas, United States, 77407

Actively Recruiting

44

Site 207

Clinton, Utah, United States, 84015

Actively Recruiting

45

Site 211

Roanoke, Virginia, United States, 24018

Actively Recruiting

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Research Team

A

Alto Neuroscience

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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