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New depression pill shows promise in Late-Stage trial

NCT ID NCT06963021

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This Phase 3 trial is testing whether an experimental drug called NBI-1065845 can help reduce depression symptoms in adults who haven't responded well to standard antidepressants. About 200 participants will take either the drug or a placebo alongside their current antidepressant for 8 weeks. The main goal is to see if the drug improves mood and daily functioning more than placebo.

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 it works, this could provide a new option for people with depression who don't get enough relief from current antidepressants alone.
What could go wrong
This is still an experimental drug, and previous studies may have shown mixed results. Even if effective, it is meant as an add-on, not a standalone cure, 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 200 people

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

Started

May 2025

Expected to finish

Jul 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 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 and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study. * Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1). * 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. * Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.

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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

    28 sites in 7 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 Clinical Site

    RECRUITING

    Chino, California, 91710, United States

  • Neurocrine Clinical Site

    RECRUITING

    Los Angeles, California, 90025, United States

  • Neurocrine Clinical Site

    RECRUITING

    Stanford, California, 94305, United States

  • Neurocrine Clinical Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Neurocrine Clinical Site

    ACTIVE_NOT_RECRUITING

    Cromwell, Connecticut, 06416, United States

  • Neurocrine Clinical Site

    ACTIVE_NOT_RECRUITING

    Farmington, Connecticut, 06030, United States

  • Neurocrine Clinical Site

    RECRUITING

    Maitland, Florida, 32751, United States

  • Neurocrine Clinical Site

    RECRUITING

    Miami, Florida, 33136, United States

  • Neurocrine Clinical Site

    WITHDRAWN

    Tampa, Florida, 33613, United States

  • Neurocrine Clinical Site

    ACTIVE_NOT_RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • Neurocrine Clinical Site

    RECRUITING

    Cedarhurst, New York, 11516, United States

  • Neurocrine Clinical Site

    ACTIVE_NOT_RECRUITING

    New York, New York, 10029, United States

  • Neurocrine Clinical Site

    RECRUITING

    New York, New York, 10128, United States

  • Neurocrine Clinical Site

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • Neurocrine Clinical Site

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Neurocrine Clinical Site

    ACTIVE_NOT_RECRUITING

    Alken, 3570, Belgium

  • Neurocrine Clinical Site

    RECRUITING

    Bruges, 8310, Belgium

  • Neurocrine Clinical Site

    RECRUITING

    Mechelen, 2800, Belgium

  • Neurocrine Clinical Site

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • Neurocrine Clinical Site

    RECRUITING

    Verdun, H4H 1R3, Canada

  • 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

    Budapest, 1083, Hungary

  • Neurocrine Clinical Site

    RECRUITING

    Budapest, 1135, Hungary

  • Neurocrine Clinical Site

    RECRUITING

    Gyöngyös, 3200, Hungary

  • Neurocrine Clinical Site

    ACTIVE_NOT_RECRUITING

    Kalocsa, 6300, Hungary

  • Neurocrine Clinical Site

    RECRUITING

    Jelgava, LV-3008, Latvia

  • Neurocrine Clinical Site

    RECRUITING

    Liepāja, LV-3401, Latvia

  • Neurocrine Clinical Site

    RECRUITING

    Sigulda, LV-2150, Latvia

  • Neurocrine Clinical Site

    RECRUITING

    London, SE5 8AZ, United Kingdom

  • Neurocrine Clinical Site

    RECRUITING

    Salford, M6 8HD, United Kingdom

  • Neurocrine Clinical Site

    RECRUITING

    Sheffield, S5 7JT, United Kingdom

  • Neurocrine Clinical Site

    RECRUITING

    Southampton, SO30 3JB, United Kingdom

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