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

NCT07553637 · tracked via the Priya Life Science UK tracker

Sponsor

Alto Neuroscience

Phase

Phase 2

Started

2026-05

Last updated

2026-04-28

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

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 (48)

Facility	City	Region	Status
Site 7074	Birmingham	Alabama	Not Yet Recruiting
Site 7173	Dothan	Alabama	Not Yet Recruiting
Site 7000	Phoenix	Arizona	Recruiting
Site 7153	Chino	California	Not Yet Recruiting
Site 7156	Oakland	California	Not Yet Recruiting
Site 7082	Oceanside	California	Recruiting
Site 7159	Palo Alto	California	Not Yet Recruiting
Site 7016	Sacramento	California	Not Yet Recruiting
Site 7144	San Diego	California	Recruiting
Site 7171	Valley Village	California	Not Yet Recruiting
Site 7152	Saint Augustine	Florida	Recruiting
Site 7148	Albany	Georgia	Recruiting
Site 7146	Atlanta	Georgia	Not Yet Recruiting
Site 7064	Peachtree Corners	Georgia	Not Yet Recruiting
Site 7141	Savannah	Georgia	Recruiting
Site 7169	Indianapolis	Indiana	Not Yet Recruiting
Site 7151	Annapolis	Maryland	Recruiting
Site 7054	Pikesville	Maryland	Not Yet Recruiting
Site 7166	Worcester	Massachusetts	Not Yet Recruiting
Site 7155	Ann Arbor	Michigan	Not Yet Recruiting
Site 7154	Bloomfield Hills	Michigan	Recruiting
Site 7170	Amherst	New York	Not Yet Recruiting
Site 7055	Cedarhurst	New York	Not Yet Recruiting
Site 7162	Lewiston	New York	Not Yet Recruiting
Site 7157	Syracuse	New York	Not Yet Recruiting
Site 7143	Charlotte	North Carolina	Recruiting
Site 7029	Cincinnati	Ohio	Recruiting
Site 7158	Garfield Heights	Ohio	Not Yet Recruiting
Site 7172	East Providence	Rhode Island	Not Yet Recruiting
Site 7176	Dallas	Texas	Not Yet Recruiting
Site 7160	Fort Worth	Texas	Not Yet Recruiting
Site 7150	Galveston	Texas	Not Yet Recruiting
Site 7175	Houston	Texas	Not Yet Recruiting
Site 7145	Houston	Texas	Recruiting
Site 7161	Irving	Texas	Recruiting
Site 7177	Fairfax	Virginia	Not Yet Recruiting
Site 7128	Seattle	Washington	Not Yet Recruiting
Site 7163	South Charleston	West Virginia	Not Yet Recruiting
Site 7419	Antrim	United Kingdom	Not Yet Recruiting
Site 7411	Birmingham	United Kingdom	Not Yet Recruiting

+ 8 more sites — see the full list on the official registry below.

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 UK