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 pill aims to keep depression away longer

NCT ID NCT07196501

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 1 time

Summary

This Phase 3 study tests whether adding NBI-1065845 to standard antidepressants can delay the return of depressive symptoms in adults with major depression. About 550 people who have not fully responded to current antidepressants will take either the study drug or a placebo pill. The main goal is to see how long it takes for depression symptoms to come back.

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 (oral tablet)
What this could lead to
If it works, this could provide a new add-on option to help people with major depression stay well longer and delay relapse.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The drug may not work better than placebo, and side effects are possible. Results may not apply to everyone 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 550 people

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

Started

Aug 2025

Expected to finish

Jul 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 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. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

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.

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

    57 sites in 11 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

    Oceanside, California, 92056, United States

  • Neurocrine Clinical Site

    RECRUITING

    Orange, California, 92868, United States

  • Neurocrine Clinical Site

    RECRUITING

    San Jose, California, 95124, United States

  • Neurocrine Clinical Site

    RECRUITING

    New Haven, Connecticut, 06520, United States

  • Neurocrine Clinical Site

    RECRUITING

    Miami Gardens, Florida, 33014, United States

  • Neurocrine Clinical Site

    RECRUITING

    Orlando, Florida, 32803, United States

  • Neurocrine Clinical Site

    RECRUITING

    Palm Bay, Florida, 32905, United States

  • Neurocrine Clinical Site

    RECRUITING

    Tampa, Florida, 33629, United States

  • Neurocrine Clinical Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Neurocrine Clinical Site

    RECRUITING

    Marrero, Louisiana, 70072, United States

  • Neurocrine Clinical Site

    RECRUITING

    O'Fallon, Missouri, 63368, United States

  • Neurocrine Clinical Site

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Neurocrine Clinical Site

    RECRUITING

    Glen Oaks, New York, 11004, United States

  • Neurocrine Clinical Site

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • Neurocrine Clinical Site

    RECRUITING

    Edmond, Oklahoma, 73013, United States

  • Neurocrine Clinical Site

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • Neurocrine Clinical Site

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Neurocrine Clinical Site

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78712, United States

  • Neurocrine Clinical Site

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Neurocrine Clinical Site

    TERMINATED

    Friendswood, Texas, 77546, United States

  • Neurocrine Clinical Site

    RECRUITING

    Stafford, Texas, 77477, United States

  • Neurocrine Clinical Site

    RECRUITING

    Wichita Falls, Texas, 76309, United States

  • Neurocrine Clinical Site

    RECRUITING

    Draper, Utah, 84020, United States

  • Neurocrine Clinical Site

    RECRUITING

    Roanoke, Virginia, 24018, United States

  • Neurocrine Clinical Site

    RECRUITING

    Carlton, Victoria, 3053, Australia

  • Neurocrine Clinical Site

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Neurocrine Clinical Site

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Neurocrine Clinical Site

    RECRUITING

    Sofia, 1303, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Sofia, 1408, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Sofia, 1510, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Sofia, 1680, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Calgary, Alberta, T2N 2T9, Canada

  • Neurocrine Clinical Site

    RECRUITING

    North Vancouver, British Columbia, V7P 2T4, Canada

  • Neurocrine Clinical Site

    RECRUITING

    Kingston, Ontario, K7L 4X3, Canada

  • Neurocrine Clinical Site

    RECRUITING

    Sherbrooke, Quebec, J1L 0H8, Canada

  • Neurocrine Clinical Site

    RECRUITING

    Toronto, M5H 1A1, Canada

  • Neurocrine Clinical Site

    RECRUITING

    Tallinn, 10138, Estonia

  • Neurocrine Clinical Site

    RECRUITING

    Tallinn, 11315, Estonia

  • Neurocrine Clinical Site

    RECRUITING

    Tartu, 50417, Estonia

  • Neurocrine Clinical Site

    WITHDRAWN

    Milan, 20127, Italy

  • Neurocrine Clinical Site

    RECRUITING

    Roma, 168, Italy

  • Neurocrine Clinical Site

    RECRUITING

    Rome, 168, Italy

  • Neurocrine Clinical Site

    RECRUITING

    Torino, 10126, Italy

  • Neurocrine Clinical Site

    RECRUITING

    Bialystok, 15-879, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Bydgoszcz, 85-794, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Gdansk, 80-283, Poland

  • Neurocrine Clinical Site

    RECRUITING

    Belgrade, 11000, Serbia

  • Neurocrine Clinical Site

    RECRUITING

    Kovin, 26220, Serbia

  • Neurocrine Clinical Site

    RECRUITING

    Kragujevac, 34000, Serbia

  • Neurocrine Clinical Site

    RECRUITING

    Ansan-si, Gyeonggi-do, 15355, South Korea

  • Neurocrine Clinical Site

    RECRUITING

    Seoul, 02841, South Korea

  • Neurocrine Clinical Site

    RECRUITING

    Seoul, 06351, South Korea

  • Neurocrine Clinical Site

    RECRUITING

    Seoul, 3181, South Korea

  • Neurocrine Clinical Site

    RECRUITING

    Alcorcón, Madrid, 28922, Spain

  • Neurocrine Clinical Site

    RECRUITING

    Barcelona, 08025, Spain

  • Neurocrine Clinical Site

    RECRUITING

    Barcelona, 08035, Spain

  • Neurocrine Clinical Site

    RECRUITING

    Keelung, 204, Taiwan

  • Neurocrine Clinical Site

    RECRUITING

    Taipei, 10449, Taiwan

  • Neurocrine Clinical Site

    RECRUITING

    Taipei, 110, Taiwan

  • Neurocrine Clinical Site

    RECRUITING

    Taipei, 11217, Taiwan

More trials for these conditions

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