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New depression pill shows promise in Late-Stage trial

NCT ID NCT06786624

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether adding NBI-1065845 to standard antidepressants can better relieve depression symptoms in adults who haven't gotten enough help from their current medication. About 200 participants will receive either the study drug or a placebo for 8 weeks. The main goal is to see if depression scores improve more with the add-on treatment.

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

Jan 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

    15 sites. 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

    Little Rock, Arkansas, 72204, United States

  • Neurocrine Clinical Site

    COMPLETED

    Garden Grove, California, 92844, 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, United States

  • Neurocrine Clinical Site

    RECRUITING

    Upland, California, 91786, United States

  • Neurocrine Clinical Site

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Neurocrine Clinical Site

    RECRUITING

    Maitland, Florida, 32751, United States

  • Neurocrine Clinical Site

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Neurocrine Clinical Site

    SUSPENDED

    Watertown, Massachusetts, 02472, United States

  • Neurocrine Clinical Site

    RECRUITING

    Mount Kisco, New York, 10549, United States

  • Neurocrine Clinical Site

    RECRUITING

    Avon Lake, Ohio, 44012, United States

  • Neurocrine Clinical Site

    COMPLETED

    Westlake, Ohio, 44145, United States

  • Neurocrine Clinical Site

    RECRUITING

    Dallas, Texas, 75251, United States

  • Neurocrine Clinical Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Neurocrine Clinical Site

    WITHDRAWN

    Richmond, Texas, 77407, United States

  • Neurocrine Clinical Site

    SUSPENDED

    The Woodlands, Texas, 77381, United States

  • Neurocrine Clinical Site

    RECRUITING

    Everett, Washington, 98201, United States

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