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New depression drug shows promise in early trial

NCT ID NCT06391593

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an experimental drug called ALTO-203 in 69 adults with moderate major depressive disorder who also had anhedonia (loss of interest or pleasure). Participants received either a low dose, a higher dose, or a placebo, and reported their mood and alertness. The goal was to see if the drug improves mood and is safe over a 28-day period.

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

69 people

The number who actually took part.

Started

Mar 2024

Finished

Apr 2025

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

25 to 64 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: * Have a diagnosis of moderate major depressive disorder (MDD) * Presence of anhedonia symptoms * Not taking antidepressant at Screening Visit 2 * Willing to comply with all study assessments and procedures Exclusion Criteria: * Evidence of unstable medical condition * Diagnosed bipolar disorder, psychotic disorder, or dementia * Concurrent use of prohibited medications * Current moderate or severe substance use disorder * 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.

Anhedonia major depressive disorder

As listed by the trial registrant

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

Anhedonia Major depressive disorder

Contacts and locations

Locations

  • Site 4005

    Orlando, Florida, 32801, United States

  • Site 4007

    Clinton, Utah, 84015, United States

  • Site 4022

    Marlton, New Jersey, 08053, United States

  • Site 4023

    Torrance, California, 90504, United States

  • Site 4031

    Atlanta, Georgia, 30030, United States

  • Site 4033

    Bellevue, Washington, 98007, United States

  • Site 4036

    Las Vegas, Nevada, 89121, United States

  • Site 4040

    Austin, Texas, 78737, United States

  • Site 4054

    Pikesville, Maryland, 21208, United States

  • Site 4058

    Tucson, Arizona, 85704, United States

  • Site 4059

    Clermont, Florida, 34711, United States

  • Site 4072

    Houston, Texas, 77081, United States

  • Site 4075

    Westlake, Ohio, 44145, United States

  • Site 4082

    Oceanside, California, 92056, United States

  • Site 4134

    Princeton, New Jersey, 08540, United States

More trials for these conditions

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