Recruiting
Phase 2

ALTO-207

Sponsor:

Alto Neuroscience

Code:

NCT07553637

Conditions

Treatment-resistant Depression (TRD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALTO-207

Placebo

Study Details

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)

Study ID

NCT07553637

Start date

May, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

178 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALTO-207

placebo comparator: Placebo

Interventions

ALTO-207

ALTO-207 BID

Placebo

Matching Placebo

Primary outcome measure

  • Change in the MADRS total score [ Time Frame: Change from baseline up to 8 weeks ]

Central Contacts and Locations

Central contacts

Alto Neuroscience

650-200-0412clinical@altoneuroscience.com

Locations

Site 7000

Recruiting

Phoenix, Arizona, United States, 85012

Site 7082

Recruiting

Oceanside, California, United States, 92056

Site 7144

Recruiting

San Diego, California, United States, 92123

Site 7152

Recruiting

Saint Augustine, Florida, United States, 32086

Site 7148

Recruiting

Albany, Georgia, United States, 31707

Site 7141

Recruiting

Savannah, Georgia, United States, 31406

Site 7151

Recruiting

Annapolis, Maryland, United States, 21401

Site 7154

Recruiting

Bloomfield Hills, Michigan, United States, 48302

Site 7143

Recruiting

Charlotte, North Carolina, United States, 28287

Site 7029

Recruiting

Cincinnati, Ohio, United States, 45215

Site 7145

Recruiting

Houston, Texas, United States, 77030

Site 7161

Recruiting

Irving, Texas, United States, 75062

More Information

Sponsor

Alto Neuroscience

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alto Neuroscience on 2026-04-28.