Back to search results

ALTO-207 for Treatment-Resistant Depression

This study is testing a drug called ALTO-207 for adults with treatment-resistant depression (TRD). TRD means that your depression hasn't gotten better after trying at least two to five other antidepressant treatments. The study will compare ALTO-207 to a placebo (an inactive pill) to see if ALTO-207 can reduce depressive symptoms. You might be able to join if you are between 18 and 75 years old, have a diagnosis of moderate to severe depression without psychotic symptoms, and have not responded to previous treatments. The main goal is to measure changes in your depression scores over 8 weeks. The current status of this study is unclear.

Study design
This study is an interventional trial planning to enroll 178 participants. It compares ALTO-207 to a matching placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes up to 8 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07553637

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Alto Neuroscience
~178 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:ALTO-207Placebo

At a glance

Recruiting sites
12 of 48 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the MADRS total score
Measured over Change from baseline up to 8 weeks

Conditions

Treatment-resistant Depression (TRD)

Explore related trials

Unipolar Depression

Where it's being run

48 sites across 18 states
United Kingdom10
California7
Texas6
Georgia4
New York4
Alabama2
Maryland2
Michigan2

Who to contact

Alto Neuroscience
[email protected]
650-200-0412
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in the MADRS total scoreChange 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.