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New depression pill shows promise in Long-Term safety trial

NCT ID NCT06966401

Symptom relief Sponsor: Neurocrine Biosciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This Phase 3 study is testing the long-term safety of an experimental drug called NBI-1065845 (TAK-653) in 850 adults with major depressive disorder who haven't gotten enough relief from standard antidepressants. Participants take the drug alongside their usual antidepressant for up to a year. The main goal is to see what side effects occur.

What this could mean

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

Active substance
NBI-1065845 (also known as TAK-653) tablets
What this could lead to
If successful, this could provide a new add-on option for people with depression who haven't responded well to standard antidepressants.
What could go wrong
This is an open-label study with no placebo group, so results may be less reliable. It focuses on safety, not effectiveness, and side effects are possible.

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 850 people

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

Started

Apr 2025

Expected to finish

May 2030

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 years and older

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.

Key Inclusion Criteria: * Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder. * Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression. * Participant must have been taking oral antidepressants for at least 8 weeks prior to screening. * Willing and able to comply with all study procedures and restrictions in the opinion of the investigator. Key Exclusion Criteria: * A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD. * Are considered by the investigator to be at imminent risk of suicide or injury to self or others. Other protocol defined inclusion and exclusion criteria apply.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

Depression dysthymic disorder major depressive disorder

As listed by the trial registrant

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

Major depressive disorder

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

    97 sites in 20 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

  • Neurocrine

    RECRUITING

    Sigulda, Lativa, LV-2150, Latvia

  • Neurocrine Clinical Site

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • Neurocrine Clinical Site

    RECRUITING

    Bryant, Arkansas, 72022, United States

  • Neurocrine Clinical Site

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Neurocrine Clinical Site

    RECRUITING

    Glendale, California, 91206, United States

  • Neurocrine Clinical Site

    RECRUITING

    Los Angeles, California, 90025, United States

  • Neurocrine Clinical Site

    RECRUITING

    Oceanside, California, 92056, United States

  • Neurocrine Clinical Site

    RECRUITING

    Orange, California, 92866, United States

  • Neurocrine Clinical Site

    RECRUITING

    Pico Rivera, California, 90660, United States

  • Neurocrine Clinical Site

    RECRUITING

    San Diego, California, 92103-8229, United States

  • Neurocrine Clinical Site

    RECRUITING

    San Francisco, California, 94107, United States

  • Neurocrine Clinical Site

    RECRUITING

    San Jose, California, 95124, United States

  • Neurocrine Clinical Site

    TERMINATED

    Upland, California, 91786, United States

  • Neurocrine Clinical Site

    RECRUITING

    Cromwell, Connecticut, 06416, United States

  • Neurocrine Clinical Site

    RECRUITING

    Farmington, Connecticut, 06030, United States

  • Neurocrine Clinical Site

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Neurocrine Clinical Site

    RECRUITING

    Maitland, Florida, 32751-5669, United States

  • Neurocrine Clinical Site

    RECRUITING

    Maitland, Florida, 32751, United States

  • Neurocrine Clinical Site

    RECRUITING

    Miami, Florida, 33174, United States

  • Neurocrine Clinical Site

    RECRUITING

    Miami Gardens, Florida, 33014, United States

  • Neurocrine Clinical Site

    WITHDRAWN

    Orlando, Florida, 32803, United States

  • Neurocrine Clinical Site

    RECRUITING

    Palm Bay, Florida, 32905, United States

  • Neurocrine Clinical Site

    RECRUITING

    Tampa, Florida, 33607, United States

  • Neurocrine Clinical Site

    RECRUITING

    Tampa, Florida, 33629, United States

  • Neurocrine Clinical Site

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Neurocrine Clinical Site

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • Neurocrine Clinical Site

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Neurocrine Clinical Site

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Neurocrine Clinical Site

    RECRUITING

    O'Fallon, Missouri, 63368, United States

  • Neurocrine Clinical Site

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Neurocrine Clinical Site

    RECRUITING

    Cedarhurst, New York, 11516, United States

  • Neurocrine Clinical Site

    RECRUITING

    Mount Kisco, New York, 10549, United States

  • Neurocrine Clinical Site

    RECRUITING

    New York, New York, 10029, United States

  • Neurocrine Clinical Site

    RECRUITING

    New York, New York, 10128, United States

  • Neurocrine Clinical Site

    RECRUITING

    The Bronx, New York, 10461, United States

  • Neurocrine Clinical Site

    RECRUITING

    Avon Lake, Ohio, 44012, United States

  • Neurocrine Clinical Site

    RECRUITING

    Edmond, Oklahoma, 73013, United States

  • Neurocrine Clinical Site

    WITHDRAWN

    Oklahoma City, Oklahoma, 73112, United States

  • Neurocrine Clinical Site

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Neurocrine Clinical Site

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Neurocrine Clinical Site

    RECRUITING

    Dallas, Texas, 75251, United States

  • Neurocrine Clinical Site

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Neurocrine Clinical Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Neurocrine Clinical Site

    WITHDRAWN

    Richmond, Texas, 77407, United States

  • Neurocrine Clinical Site

    RECRUITING

    Stafford, Texas, 77477, United States

  • Neurocrine Clinical Site

    RECRUITING

    The Woodlands, Texas, 77381, United States

  • Neurocrine Clinical Site

    RECRUITING

    Everett, Washington, 98201, United States

  • Neurocrine Clinical Site

    RECRUITING

    Alken, 3570, Belgium

  • Neurocrine Clinical Site

    RECRUITING

    Mechelen, 2800, Belgium

  • Neurocrine Clinical Site

    RECRUITING

    Kardzhali, 7003, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Plovdiv, 4400, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Sofia, 1113, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Sofia, 1408, Bulgaria

  • Neurocrine Clinical Site

    WITHDRAWN

    Sofia, 1510, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Sofia, 1510, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Sofia, 1680, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Varna, 9020, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Toronto, Ontario, M5H 1A1, Canada

  • Neurocrine Clinical Site

    RECRUITING

    Zagreb, 10000, Croatia

  • Neurocrine Clinical Site

    RECRUITING

    Zagreb, 10090, Croatia

  • Neurocrine Clinical Site

    RECRUITING

    Pilsen, 30100, Czechia

  • Neurocrine Clinical Site

    RECRUITING

    Prague, 100 00, Czechia

  • Neurocrine Clinical Site

    RECRUITING

    Prague, 11000, Czechia

  • Neurocrine Clinical Site

    RECRUITING

    Prague, 160 00, Czechia

  • Neurocrine Clinical Site

    RECRUITING

    Prague, 186 00, Czechia

  • Neurocrine Clinical Site

    RECRUITING

    Tallinn, 11315, Estonia

  • Neurocrine Clinical Site

    RECRUITING

    Kuopio, 70110, Finland

  • Neurocrine Clinical Site

    RECRUITING

    Oulu, 90100, Finland

  • Neurocrine Clinical Site

    RECRUITING

    Tampere, 33210, Finland

  • Neurocrine Clinical Site

    RECRUITING

    Budapest, 1036, Hungary

  • Neurocrine Clinical Site

    RECRUITING

    Roma, 00168, Italy

  • Neurocrine Clinical Site

    RECRUITING

    Jelgava, Lativa, LV-3008, Latvia

  • Neurocrine Clinical Site

    RECRUITING

    Liepāja, Lativa, LV-3401, Latvia

  • Neurocrine Clinical Site

    RECRUITING

    Jelgava, LV-3008, Latvia

  • Neurocrine Clinical Site

    RECRUITING

    Liepāja, LV-3401, Latvia

  • Neurocrine Clinical Site

    RECRUITING

    Kaunas, LT-44279, Lithuania

  • Neurocrine Clinical Site

    RECRUITING

    Kaunas, LT-49449, Lithuania

  • Neurocrine Clinical Site

    RECRUITING

    Amsterdam, 1081 GN, Netherlands

  • Neurocrine Clinical Site

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Neurocrine Clinical Site

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Neurocrine Clinical Site

    RECRUITING

    Bełchatów, 97-400, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Bialystok, 15-404, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Bialystok, 15-756, Poland

  • Neurocrine Clinical Site

    WITHDRAWN

    Bialystok, 15-879, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Bydgoszcz, 85-794, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Gdansk, 80-283, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Gdansk, 80-546, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Grudziądz, 86-300, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Katowice, 40-514, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Craiova, 200157, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Bojnice, 97201, Slovakia

  • Neurocrine Clinical Site

    RECRUITING

    Bratislava, 820 07, Slovakia

  • Neurocrine Clinical Site

    RECRUITING

    Košice, 04001, Slovakia

  • Neurocrine Clinical Site

    RECRUITING

    Rimavská Sobota, 979 01, Slovakia

  • Neurocrine Clinical Site

    RECRUITING

    Svidník, 089 01, Slovakia

  • Neurocrine Clinical Site

    RECRUITING

    Vranov nad Topľou, 093 01, Slovakia

  • Neurocrine Clinical Site

    RECRUITING

    Madrid, 28922, Spain

  • Neurocrine Clinical Site

    RECRUITING

    Gothenburg, 41345, Sweden

  • Neurocrine Clinical Site

    RECRUITING

    Lund, 222 22, Sweden

  • Neurocrine Clinical Site

    RECRUITING

    Stockholm, 113 29, Sweden

  • Neurocrine Clinical Site

    RECRUITING

    Keelung, 204, Taiwan

  • Neurocrine Clinical Site

    WITHDRAWN

    Taipei, 112201, Taiwan

  • Neurocrine Clinical Site

    WITHDRAWN

    Southampton, Hampshire, SO30 3JB, United Kingdom

  • Neurocrine Clinical Site

    RECRUITING

    Sheffield, South Yorkshire, S3 7ND, United Kingdom

  • Neurocrine Clinical Site

    RECRUITING

    London, SE5 8AF, United Kingdom

  • Neurocrine Clinical Site

    WITHDRAWN

    Manchester, M25 3BL, United Kingdom

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