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New hope for tough depression: ALTO-207 trial launches

NCT ID NCT07553637

Symptom relief Sponsor: Alto Neuroscience Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called ALTO-207 in adults whose depression has not improved with at least two prior treatments. About 178 participants will receive either the drug or a placebo for several weeks. The main goal is to see if ALTO-207 reduces depression symptoms better than placebo, using a standard rating scale.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 178 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Treatment resistant depression (TRD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    48 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Site 7000

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Site 7016

    NOT_YET_RECRUITING

    Sacramento, California, 95655, United States

  • Site 7029

    RECRUITING

    Cincinnati, Ohio, 45215, United States

  • Site 7054

    NOT_YET_RECRUITING

    Pikesville, Maryland, 21208, United States

  • Site 7055

    NOT_YET_RECRUITING

    Cedarhurst, New York, 11516, United States

  • Site 7064

    NOT_YET_RECRUITING

    Peachtree Corners, Georgia, 30078, United States

  • Site 7074

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35294, United States

  • Site 7082

    RECRUITING

    Oceanside, California, 92056, United States

  • Site 7128

    NOT_YET_RECRUITING

    Seattle, Washington, 98004, United States

  • Site 7141

    RECRUITING

    Savannah, Georgia, 31406, United States

  • Site 7143

    RECRUITING

    Charlotte, North Carolina, 28287, United States

  • Site 7144

    RECRUITING

    San Diego, California, 92123, United States

  • Site 7145

    RECRUITING

    Houston, Texas, 77030, United States

  • Site 7146

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30060, United States

  • Site 7148

    RECRUITING

    Albany, Georgia, 31707, United States

  • Site 7150

    NOT_YET_RECRUITING

    Galveston, Texas, 77555, United States

  • Site 7151

    RECRUITING

    Annapolis, Maryland, 21401, United States

  • Site 7152

    RECRUITING

    Saint Augustine, Florida, 32086, United States

  • Site 7153

    NOT_YET_RECRUITING

    Chino, California, 91710, United States

  • Site 7154

    RECRUITING

    Bloomfield Hills, Michigan, 48302, United States

  • Site 7155

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Site 7156

    NOT_YET_RECRUITING

    Oakland, California, 94610, United States

  • Site 7157

    NOT_YET_RECRUITING

    Syracuse, New York, 13210, United States

  • Site 7158

    NOT_YET_RECRUITING

    Garfield Heights, Ohio, 44125, United States

  • Site 7159

    NOT_YET_RECRUITING

    Palo Alto, California, 94304, United States

  • Site 7160

    NOT_YET_RECRUITING

    Fort Worth, Texas, 76104, United States

  • Site 7161

    RECRUITING

    Irving, Texas, 75062, United States

  • Site 7162

    NOT_YET_RECRUITING

    Lewiston, New York, 14214, United States

  • Site 7163

    NOT_YET_RECRUITING

    South Charleston, West Virginia, 25303, United States

  • Site 7166

    NOT_YET_RECRUITING

    Worcester, Massachusetts, 01606, United States

  • Site 7169

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Site 7170

    NOT_YET_RECRUITING

    Amherst, New York, 14226, United States

  • Site 7171

    NOT_YET_RECRUITING

    Valley Village, California, 91607, United States

  • Site 7172

    NOT_YET_RECRUITING

    East Providence, Rhode Island, 02914, United States

  • Site 7173

    NOT_YET_RECRUITING

    Dothan, Alabama, 36345, United States

  • Site 7175

    NOT_YET_RECRUITING

    Houston, Texas, 77007, United States

  • Site 7176

    NOT_YET_RECRUITING

    Dallas, Texas, 75243, United States

  • Site 7177

    NOT_YET_RECRUITING

    Fairfax, Virginia, 22030, United States

  • Site 7402

    NOT_YET_RECRUITING

    Prescot, United Kingdom

  • Site 7410

    NOT_YET_RECRUITING

    Oxford, United Kingdom

  • Site 7411

    NOT_YET_RECRUITING

    Birmingham, United Kingdom

  • Site 7412

    NOT_YET_RECRUITING

    Cardiff, United Kingdom

  • Site 7413

    NOT_YET_RECRUITING

    Nottingham, United Kingdom

  • Site 7414

    NOT_YET_RECRUITING

    Bristol, United Kingdom

  • Site 7415

    NOT_YET_RECRUITING

    London, United Kingdom

  • Site 7416

    NOT_YET_RECRUITING

    Sheffield, United Kingdom

  • Site 7418

    NOT_YET_RECRUITING

    Exeter, United Kingdom

  • Site 7419

    NOT_YET_RECRUITING

    Antrim, United Kingdom

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Other studies related to the condition(s) this trial covers.