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New drug milsaperidone aims to boost depression treatment

NCT ID NCT06830044

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study tests whether adding milsaperidone to standard antidepressant therapy helps adults with major depressive disorder who still have symptoms. About 500 participants will receive either milsaperidone or a placebo, and researchers will measure changes in depression severity using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
milsaperidone (also called VHX-896)
What this could lead to
If it works, this could provide a new add-on treatment option for people with major depressive disorder who haven't gotten enough relief from standard antidepressants.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The drug may not prove more effective than placebo, and side effects are possible. Results may not apply to all patients with depression.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

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

Started

Mar 2025

Expected to finish

Mar 2028

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 65 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 or female patient 18 to 65 years of age, inclusive; * Meets DSM-5-TR criteria for MDD * Currently having an inadequate response to antidepressant therapy as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) Exclusion Criteria: * Within the patients lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD * Within 6 months of Screening, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD * Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment

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Get notified about this study

Sign up to get updates when this study changes or when new studies for Major depressive disorder (MDD) are added.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    36 sites in 4 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

  • Vanda Investigational Site

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Vanda Investigational Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Vanda Investigational Site

    RECRUITING

    Garden Grove, California, 92845, United States

  • Vanda Investigational Site

    RECRUITING

    Lemon Grove, California, 91945, United States

  • Vanda Investigational Site

    RECRUITING

    Orange, California, 92868, United States

  • Vanda Investigational Site

    RECRUITING

    San Jose, California, 95124, United States

  • Vanda Investigational Site

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Vanda Investigational Site

    RECRUITING

    Colorado Springs, Colorado, 80910, United States

  • Vanda Investigational Site

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • Vanda Investigational Site

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33135, United States

  • Vanda Investigational Site

    RECRUITING

    Miami, Florida, 33173, United States

  • Vanda Investigational Site

    ACTIVE_NOT_RECRUITING

    Tampa, Florida, 33614, United States

  • Vanda Investigational Site

    RECRUITING

    Chicago, Illinois, 60634, United States

  • Vanda Investigational Site

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Vanda Investigational Site

    RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Vanda Investigational Site

    RECRUITING

    New York, New York, 10035, United States

  • Vanda Investigational Site

    RECRUITING

    Staten Island, New York, 10314, United States

  • Vanda Investigational Site

    RECRUITING

    Media, Pennsylvania, 19063, United States

  • Vanda Investigational Site

    RECRUITING

    Richardson, Texas, 75080, United States

  • Vanda Investigational Site

    RECRUITING

    Witchita Falls, Texas, 76309, United States

  • Vanda Investigational Site

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Vanda Investigational Site

    RECRUITING

    Sofia, 1202, Bulgaria

  • Vanda Investigational Site

    RECRUITING

    Sofia, 1618, Bulgaria

  • Vanda Investigational Site

    RECRUITING

    Sofia, 1680, Bulgaria

  • Vanda Investigational Site

    RECRUITING

    Targovishte, 7700, Bulgaria

  • Vanda Investigational Site

    RECRUITING

    Varna, 9020, Bulgaria

  • Vanda Investigational Site

    RECRUITING

    Brno, 60200, Czechia

  • Vanda Investigational Site

    RECRUITING

    Pilsen, 30100, Czechia

  • Vanda Investigational Site

    RECRUITING

    Poruba, 70800, Czechia

  • Vanda Investigational Site

    RECRUITING

    Prague, 100 00, Czechia

  • Vanda Investigational Site

    RECRUITING

    Prague, 15000, Czechia

  • Vanda Investigational Site

    RECRUITING

    Prague, 16000, Czechia

  • Vanda Investigational Site

    RECRUITING

    Bialystok, 15-756, Poland

  • Vanda Investigational Site

    RECRUITING

    Bydgoszcz, 85-794, Poland

  • Vanda Investigational Site

    RECRUITING

    Gdansk, 80-952, Poland

  • Vanda Investigational Site

    RECRUITING

    Katowice, 40-514, Poland

  • Vanda Investigational Site

    RECRUITING

    Katowice, 40-600, Poland

  • Vanda Investigational Site

    RECRUITING

    Suchy Las, 62-002, Poland

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