Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New depression pill shows promise in Late-Stage trial

NCT ID NCT06911112

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether adding NBI-1065845 to standard antidepressants can better ease depression symptoms in 200 adults who haven't fully responded to current treatments. Participants take the drug or a placebo for 8 weeks, and doctors measure changes in mood and daily functioning. The goal is to see if this new option can help when usual antidepressants fall short.

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 called TAK-653) tablets
What this could lead to
If it works, this could offer a new add-on option for people with major depression who don't get enough relief from standard antidepressants alone.
What could go wrong
This is still an experimental drug. Even in Phase 3, it may not prove more effective than placebo, and side effects are possible. Results may not apply to all depression types.

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

Mar 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.

Get updates

Get notified about this study

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

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

    34 sites in 5 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

    Huntsville, Alabama, 35801, United States

  • Neurocrine Clinical Site

    RECRUITING

    Bryant, Arkansas, 72022, United States

  • Neurocrine Clinical Site

    RECRUITING

    Glendale, California, 91206, United States

  • Neurocrine Clinical Site

    WITHDRAWN

    Irvine, California, 92614, United States

  • Neurocrine Clinical Site

    RECRUITING

    Redlands, California, 92373, United States

  • Neurocrine Clinical Site

    RECRUITING

    San Francisco, California, 94107, United States

  • Neurocrine Clinical Site

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Neurocrine Clinical Site

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33174, United States

  • Neurocrine Clinical Site

    RECRUITING

    Tampa, Florida, 33634, United States

  • Neurocrine Clinical Site

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Neurocrine Clinical Site

    WITHDRAWN

    Boston, Massachusetts, 02131, United States

  • Neurocrine Clinical Site

    ACTIVE_NOT_RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Neurocrine Clinical Site

    RECRUITING

    New York, New York, 10029, United States

  • Neurocrine Clinical Site

    ACTIVE_NOT_RECRUITING

    The Bronx, New York, 10461, United States

  • Neurocrine Clinical Site

    RECRUITING

    Mason, Ohio, 45040, United States

  • Neurocrine Clinical Site

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Neurocrine Clinical Site

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Neurocrine Clinical Site

    RECRUITING

    Kardzhali, 6600, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Plovdiv, 4004, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Rousse, 7003, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Sofia, 1113, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Sofia, 1510, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Varna, 9020, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Kaunas, LT-44279, Lithuania

  • Neurocrine Clinical Site

    RECRUITING

    Kaunas, LT-49449, Lithuania

  • Neurocrine Clinical Site

    RECRUITING

    Kaunas, LT-53137, Lithuania

  • Neurocrine Clinical Site

    RECRUITING

    Klaipėda, LT-91251, Lithuania

  • Neurocrine Clinical Site

    RECRUITING

    Vilnius, LT-10309, Lithuania

  • Neurocrine Clinical Site

    RECRUITING

    Bucharest, 041914, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Bucharest, 60222, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Craiova, 200157, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Oradea, 410154, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Banská Bystrica, 974 01, Slovakia

  • Neurocrine Clinical Site

    RECRUITING

    Bojnice, 972 01, Slovakia

  • Neurocrine Clinical Site

    RECRUITING

    Bratislava, 820 07, Slovakia

  • Neurocrine Clinical Site

    RECRUITING

    Košice, 040 01, 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

More trials for these conditions

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