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Clinical Trials in the USA / NCT07553637
Recruiting Phase 2

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

NCT07553637 · tracked via the Priya Life Science USA tracker
Sponsor
Alto Neuroscience
Phase
Phase 2
Started
2026-05-20
Last updated
2026-10-26

Condition(s) studied

Treatment-resistant Depression (TRD)

Investigational drug(s) / intervention(s)

ALTO-207Placebo

ALTO-207: ALTO-207 BID

Placebo: Matching Placebo

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in the MADRS total score — Change from baseline up to 8 weeks
    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.

Trial sites (63)

FacilityCityRegionStatus
Site 7173 Dothan Alabama Recruiting
Site 7000 Phoenix Arizona Recruiting
Site 7153 Chino California Recruiting
Site 7195 La Jolla California Not Yet Recruiting
Site 7069 Los Angeles California Recruiting
Site 7156 Oakland California Recruiting
Site 7082 Oceanside California Recruiting
Site 7159 Palo Alto California Not Yet Recruiting
Site 7016 Sacramento California Recruiting
Site 7144 San Diego California Recruiting
Site 7120 San Jose California Recruiting
Site 7171 Valley Village California Recruiting
Site 7200 Wilton Connecticut Not Yet Recruiting
Site 7152 Saint Augustine Florida Recruiting
Site 7148 Albany Georgia Recruiting
Site 7146 Marietta Georgia Recruiting
Site 7141 Savannah Georgia Recruiting
Site 7064 Snellville Georgia Recruiting
Site 7192 Naperville Illinois Recruiting
Site 7169 Indianapolis Indiana Recruiting
Site 7151 Annapolis Maryland Withdrawn
Site 7185 Baltimore Maryland Not Yet Recruiting
Site 7054 Pikesville Maryland Recruiting
Site 7180 Rockville Maryland Recruiting
Site 7166 Worcester Massachusetts Recruiting
Site 7155 Ann Arbor Michigan Recruiting
Site 7154 Bloomfield Hills Michigan Recruiting
Site 7178 Grand Rapids Michigan Not Yet Recruiting
Site 7189 St Louis Missouri Recruiting
Site 7066 Toms River New Jersey Recruiting
Site 7170 Amherst New York Recruiting
Site 7055 Cedarhurst New York Recruiting
Site 7162 Lewiston New York Recruiting
Site 7157 Syracuse New York Recruiting
Site 7127 Cary North Carolina Recruiting
Site 7143 Charlotte North Carolina Recruiting
Site 7029 Cincinnati Ohio Recruiting
Site 7194 Dayton Ohio Not Yet Recruiting
Site 7158 Garfield Heights Ohio Recruiting
Site 7172 East Providence Rhode Island Recruiting

+ 23 more sites — see the full list on the official registry below.

More Alto Neuroscience trials in the USA

Study of ALTO-101 in Patients With Schizophrenia Recruiting
Study of ALTO-300 in MDD Recruiting
ALTO-100 in Bipolar Disorder With Depression (BD-D) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07553637 on ClinicalTrials.gov ↗ ← All trials in the USA