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NCT Number: NCT07553637

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

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

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Key information

Conditions

Treatment-resistant Depression (TRD) Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 7419, Antrim, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALTO-207

Drug

ALTO-207 BID

Placebo

Drug

Matching Placebo

Primary outcomes

  1. Change in the MADRS total score

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: Change from baseline up to 8 weeks

    The Clinician Global Impression-Severity scale (CGI-S) is a 7-point global assessment scale that measures the clinician's impression of the severity of illness exhibited by a participant, rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores represent a more severe condition.

Study contacts

Contact information is provided by the study sponsor or research team.

Alto Neuroscience

CONTACT

[email protected]

650-200-0412

Sponsors and collaborators

Lead sponsor

Alto Neuroscience

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Trial of ALTO-207 in Adults With Treatment-resistant Depression

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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