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New depression pill shows promise in Late-Stage trial

NCT ID NCT06963021

Recruiting now Symptom relief Sponsor: Neurocrine Biosciences Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

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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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• 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

    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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