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

NCT07553637 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ALTO-207-201
• Study Type: interventional
• Target: 178
• Locations: 2 countries
• Sites: 48

Brief Summary

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

Conditions

Treatment-resistant Depression (TRD)

Outcome Measures

Primary Outcomes (1)

• Change in the MADRS total score

  Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

  Change from baseline up to 8 weeks

Secondary Outcomes (2)

• Change in response (≥50% improvement) raters based on MADRS

  Change from baseline up to 8 weeks

• Change in the Clinician-administered CGI-S score over time from Baseline to Week 8

  Change from baseline up to 8 weeks

Study Arms (2)

ALTO-207

EXPERIMENTAL

Drug: ALTO-207

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALTO-207 DRUG

ALTO-207 BID

ALTO-207

Placebo DRUG

Matching Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
• Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
• Failure to respond (\<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
• Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline

You may not qualify if:

• 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
• Has a history of hypersensitivity or allergic reaction to ALTO-207 or any of its components/excipients
• Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Sponsors & Collaborators

• Alto Neuroscience: lead

Study Sites (48)

Site 7074

Birmingham, Alabama, 35294, United States

NOT YET RECRUITING

Site 7173

Dothan, Alabama, 36345, United States

NOT YET RECRUITING

Site 7000

Phoenix, Arizona, 85012, United States

RECRUITING

Site 7153

Chino, California, 91710, United States

NOT YET RECRUITING

Site 7156

Oakland, California, 94610, United States

NOT YET RECRUITING

Site 7082

Oceanside, California, 92056, United States

RECRUITING

Site 7159

Palo Alto, California, 94304, United States

NOT YET RECRUITING

Site 7016

Sacramento, California, 95655, United States

NOT YET RECRUITING

Site 7144

San Diego, California, 92123, United States

RECRUITING

Site 7171

Valley Village, California, 91607, United States

NOT YET RECRUITING

Site 7152

Saint Augustine, Florida, 32086, United States

RECRUITING

Site 7148

Albany, Georgia, 31707, United States

RECRUITING

Site 7146

Atlanta, Georgia, 30060, United States

NOT YET RECRUITING

Site 7064

Peachtree Corners, Georgia, 30078, United States

NOT YET RECRUITING

Site 7141

Savannah, Georgia, 31406, United States

RECRUITING

Site 7169

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

Site 7151

Annapolis, Maryland, 21401, United States

RECRUITING

Site 7054

Pikesville, Maryland, 21208, United States

NOT YET RECRUITING

Site 7166

Worcester, Massachusetts, 01606, United States

NOT YET RECRUITING

Site 7155

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Site 7154

Bloomfield Hills, Michigan, 48302, United States

RECRUITING

Site 7170

Amherst, New York, 14226, United States

NOT YET RECRUITING

Site 7055

Cedarhurst, New York, 11516, United States

NOT YET RECRUITING

Site 7162

Lewiston, New York, 14214, United States

NOT YET RECRUITING

Site 7157

Syracuse, New York, 13210, United States

NOT YET RECRUITING

Site 7143

Charlotte, North Carolina, 28287, United States

RECRUITING

Site 7029

Cincinnati, Ohio, 45215, United States

RECRUITING

Site 7158

Garfield Heights, Ohio, 44125, United States

NOT YET RECRUITING

Site 7172

East Providence, Rhode Island, 02914, United States

NOT YET RECRUITING

Site 7176

Dallas, Texas, 75243, United States

NOT YET RECRUITING

Site 7160

Fort Worth, Texas, 76104, United States

NOT YET RECRUITING

Site 7150

Galveston, Texas, 77555, United States

NOT YET RECRUITING

Site 7175

Houston, Texas, 77007, United States

NOT YET RECRUITING

Site 7145

Houston, Texas, 77030, United States

RECRUITING

Site 7161

Irving, Texas, 75062, United States

RECRUITING

Site 7177

Fairfax, Virginia, 22030, United States

NOT YET RECRUITING

Site 7128

Seattle, Washington, 98004, United States

NOT YET RECRUITING

Site 7163

South Charleston, West Virginia, 25303, United States

NOT YET RECRUITING

Site 7419

Antrim, United Kingdom

NOT YET RECRUITING

Site 7411

Birmingham, United Kingdom

NOT YET RECRUITING

Site 7414

Bristol, United Kingdom

NOT YET RECRUITING

Site 7412

Cardiff, United Kingdom

NOT YET RECRUITING

Site 7418

Exeter, United Kingdom

NOT YET RECRUITING

Site 7415

London, United Kingdom

NOT YET RECRUITING

Site 7413

Nottingham, United Kingdom

NOT YET RECRUITING

Site 7410

Oxford, United Kingdom

NOT YET RECRUITING

Site 7402

Prescot, United Kingdom

NOT YET RECRUITING

Site 7416

Sheffield, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Alto Neuroscience

CONTACT

650-200-0412; clinical@altoneuroscience.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (38); GB (10)