Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07553637

ALTO-207 in Adults With Treatment-resistant Depression (TRD)

Led by Alto Neuroscience · Updated on 2026-04-28

178

Participants Needed

48

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.

CONDITIONS

Official Title

ALTO-207 in Adults With Treatment-resistant Depression (TRD)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF
  • Prior diagnosis of major depressive disorder without psychotic symptoms in the current episode
  • Confirmed diagnosis of current moderate to severe major depressive disorder
  • Failure to respond (less than 50% improvement) to at least 2 to 5 antidepressant treatments including current treatment
  • Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline
Not Eligible

You will not qualify if you...

  • Evidence of unstable medical condition
  • Concurrent use of any prohibited medications or substance use disorder
  • Diagnosed bipolar disorder or a psychotic disorder or symptoms
  • Significant current PTSD symptoms or history of PTSD
  • Clinically significant current impulse control difficulties
  • History of hypersensitivity or allergic reaction to ALTO-207 or its components/excipients
  • Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 48 locations

1

Site 7074

Birmingham, Alabama, United States, 35294

Not Yet Recruiting

2

Site 7173

Dothan, Alabama, United States, 36345

Not Yet Recruiting

3

Site 7000

Phoenix, Arizona, United States, 85012

Actively Recruiting

4

Site 7153

Chino, California, United States, 91710

Not Yet Recruiting

5

Site 7156

Oakland, California, United States, 94610

Not Yet Recruiting

6

Site 7082

Oceanside, California, United States, 92056

Actively Recruiting

7

Site 7159

Palo Alto, California, United States, 94304

Not Yet Recruiting

8

Site 7016

Sacramento, California, United States, 95655

Not Yet Recruiting

9

Site 7144

San Diego, California, United States, 92123

Actively Recruiting

10

Site 7171

Valley Village, California, United States, 91607

Not Yet Recruiting

11

Site 7152

Saint Augustine, Florida, United States, 32086

Actively Recruiting

12

Site 7148

Albany, Georgia, United States, 31707

Actively Recruiting

13

Site 7146

Atlanta, Georgia, United States, 30060

Not Yet Recruiting

14

Site 7064

Peachtree Corners, Georgia, United States, 30078

Not Yet Recruiting

15

Site 7141

Savannah, Georgia, United States, 31406

Actively Recruiting

16

Site 7169

Indianapolis, Indiana, United States, 46202

Not Yet Recruiting

17

Site 7151

Annapolis, Maryland, United States, 21401

Actively Recruiting

18

Site 7054

Pikesville, Maryland, United States, 21208

Not Yet Recruiting

19

Site 7166

Worcester, Massachusetts, United States, 01606

Not Yet Recruiting

20

Site 7155

Ann Arbor, Michigan, United States, 48109

Not Yet Recruiting

21

Site 7154

Bloomfield Hills, Michigan, United States, 48302

Actively Recruiting

22

Site 7170

Amherst, New York, United States, 14226

Not Yet Recruiting

23

Site 7055

Cedarhurst, New York, United States, 11516

Not Yet Recruiting

24

Site 7162

Lewiston, New York, United States, 14214

Not Yet Recruiting

25

Site 7157

Syracuse, New York, United States, 13210

Not Yet Recruiting

26

Site 7143

Charlotte, North Carolina, United States, 28287

Actively Recruiting

27

Site 7029

Cincinnati, Ohio, United States, 45215

Actively Recruiting

28

Site 7158

Garfield Heights, Ohio, United States, 44125

Not Yet Recruiting

29

Site 7172

East Providence, Rhode Island, United States, 02914

Not Yet Recruiting

30

Site 7176

Dallas, Texas, United States, 75243

Not Yet Recruiting

31

Site 7160

Fort Worth, Texas, United States, 76104

Not Yet Recruiting

32

Site 7150

Galveston, Texas, United States, 77555

Not Yet Recruiting

33

Site 7175

Houston, Texas, United States, 77007

Not Yet Recruiting

34

Site 7145

Houston, Texas, United States, 77030

Actively Recruiting

35

Site 7161

Irving, Texas, United States, 75062

Actively Recruiting

36

Site 7177

Fairfax, Virginia, United States, 22030

Not Yet Recruiting

37

Site 7128

Seattle, Washington, United States, 98004

Not Yet Recruiting

38

Site 7163

South Charleston, West Virginia, United States, 25303

Not Yet Recruiting

39

Site 7419

Antrim, United Kingdom

Not Yet Recruiting

40

Site 7411

Birmingham, United Kingdom

Not Yet Recruiting

41

Site 7414

Bristol, United Kingdom

Not Yet Recruiting

42

Site 7412

Cardiff, United Kingdom

Not Yet Recruiting

43

Site 7418

Exeter, United Kingdom

Not Yet Recruiting

44

Site 7415

London, United Kingdom

Not Yet Recruiting

45

Site 7413

Nottingham, United Kingdom

Not Yet Recruiting

46

Site 7410

Oxford, United Kingdom

Not Yet Recruiting

47

Site 7402

Prescot, United Kingdom

Not Yet Recruiting

48

Site 7416

Sheffield, United Kingdom

Not Yet 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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ALTO-207 in Adults With Treatment-resistant Depression (TRD) | DecenTrialz