New depression pill shows promise in Long-Term safety trial

NCT ID NCT06966401

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 3 study is testing the long-term safety of an experimental drug called NBI-1065845 (TAK-653) in 850 adults with major depressive disorder who haven't gotten enough relief from standard antidepressants. Participants take the drug alongside their usual antidepressant for up to a year. The main goal is to see what side effects occur.

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 successful, this could provide a new add-on option for people with depression who haven't responded well to standard antidepressants.

What could go wrong

This is an open-label study with no placebo group, so results may be less reliable. It focuses on safety, not effectiveness, and side effects are possible.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Neurocrine
RECRUITING

Sigulda, Lativa, LV-2150, Latvia
Neurocrine Clinical Site
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Huntsville, Alabama, 35801, United States
Neurocrine Clinical Site
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Bryant, Arkansas, 72022, United States
Neurocrine Clinical Site
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Little Rock, Arkansas, 72204, United States
Neurocrine Clinical Site
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Glendale, California, 91206, United States
Neurocrine Clinical Site
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Los Angeles, California, 90025, United States
Neurocrine Clinical Site
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Oceanside, California, 92056, United States
Neurocrine Clinical Site
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Orange, California, 92866, United States
Neurocrine Clinical Site
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Pico Rivera, California, 90660, United States
Neurocrine Clinical Site
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San Diego, California, 92103-8229, United States
Neurocrine Clinical Site
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San Francisco, California, 94107, United States
Neurocrine Clinical Site
TERMINATED

Upland, California, 91786, United States
Neurocrine Clinical Site
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Cromwell, Connecticut, 06416, United States
Neurocrine Clinical Site
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Farmington, Connecticut, 06030, United States
Neurocrine Clinical Site
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Hollywood, Florida, 33024, United States
Neurocrine Clinical Site
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Maitland, Florida, 32751-5669, United States
Neurocrine Clinical Site
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Maitland, Florida, 32751, United States
Neurocrine Clinical Site
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Miami, Florida, 33174, United States
Neurocrine Clinical Site
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Miami Gardens, Florida, 33014, United States
Neurocrine Clinical Site
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Orlando, Florida, 32803, United States
Neurocrine Clinical Site
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Palm Bay, Florida, 32905, United States
Neurocrine Clinical Site
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Tampa, Florida, 33607, United States
Neurocrine Clinical Site
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Tampa, Florida, 33629, United States
Neurocrine Clinical Site
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Atlanta, Georgia, 30318, United States
Neurocrine Clinical Site
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Gaithersburg, Maryland, 20877, United States
Neurocrine Clinical Site
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Boston, Massachusetts, 02116, United States
Neurocrine Clinical Site
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Watertown, Massachusetts, 02472, United States
Neurocrine Clinical Site
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O'Fallon, Missouri, 63368, United States
Neurocrine Clinical Site
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Saint Charles, Missouri, 63304, United States
Neurocrine Clinical Site
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Cedarhurst, New York, 11516, United States
Neurocrine Clinical Site
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Mount Kisco, New York, 10549, United States
Neurocrine Clinical Site
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New York, New York, 10029, United States
Neurocrine Clinical Site
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New York, New York, 10128, United States
Neurocrine Clinical Site
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The Bronx, New York, 10461, United States
Neurocrine Clinical Site
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Avon Lake, Ohio, 44012, United States
Neurocrine Clinical Site
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Edmond, Oklahoma, 73013, United States
Neurocrine Clinical Site
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Oklahoma City, Oklahoma, 73112, United States
Neurocrine Clinical Site
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Philadelphia, Pennsylvania, 19104, United States
Neurocrine Clinical Site
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Bellaire, Texas, 77401, United States
Neurocrine Clinical Site
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Dallas, Texas, 75251, United States
Neurocrine Clinical Site
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Houston, Texas, 77030, United States
Neurocrine Clinical Site
WITHDRAWN

Richmond, Texas, 77407, United States
Neurocrine Clinical Site
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Stafford, Texas, 77477, United States
Neurocrine Clinical Site
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The Woodlands, Texas, 77381, United States
Neurocrine Clinical Site
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Everett, Washington, 98201, United States
Neurocrine Clinical Site
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Alken, 3570, Belgium
Neurocrine Clinical Site
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Mechelen, 2800, Belgium
Neurocrine Clinical Site
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Kardzhali, 7003, Bulgaria
Neurocrine Clinical Site
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Plovdiv, 4400, Bulgaria
Neurocrine Clinical Site
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Sofia, 1113, Bulgaria
Neurocrine Clinical Site
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Sofia, 1408, Bulgaria
Neurocrine Clinical Site
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Sofia, 1510, Bulgaria
Neurocrine Clinical Site
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Sofia, 1680, Bulgaria
Neurocrine Clinical Site
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Varna, 9020, Bulgaria
Neurocrine Clinical Site
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Zagreb, 10000, Croatia
Neurocrine Clinical Site
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Zagreb, 10090, Croatia
Neurocrine Clinical Site
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Pilsen, 30100, Czechia
Neurocrine Clinical Site
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Prague, 100 00, Czechia
Neurocrine Clinical Site
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Prague, 11000, Czechia
Neurocrine Clinical Site
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Prague, 160 00, Czechia
Neurocrine Clinical Site
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Prague, 186 00, Czechia
Neurocrine Clinical Site
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Tallinn, 11315, Estonia
Neurocrine Clinical Site
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Kuopio, 70110, Finland
Neurocrine Clinical Site
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Oulu, 90100, Finland
Neurocrine Clinical Site
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Tampere, 33210, Finland
Neurocrine Clinical Site
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Budapest, 1036, Hungary
Neurocrine Clinical Site
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Jelgava, Lativa, LV-3008, Latvia
Neurocrine Clinical Site
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Liepāja, Lativa, LV-3401, Latvia
Neurocrine Clinical Site
RECRUITING

Jelgava, LV-3008, Latvia
Neurocrine Clinical Site
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Liepāja, LV-3401, Latvia
Neurocrine Clinical Site
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Kaunas, LT-44279, Lithuania
Neurocrine Clinical Site
NOT_YET_RECRUITING

Amsterdam, 1081 GN, Netherlands
Neurocrine Clinical Site
NOT_YET_RECRUITING

Groningen, 9713 GZ, Netherlands
Neurocrine Clinical Site
NOT_YET_RECRUITING

Leiden, 2333 ZA, Netherlands
Neurocrine Clinical Site
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Bełchatów, 97-400, Poland
Neurocrine Clinical Site
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Bialystok, 15-404, Poland
Neurocrine Clinical Site
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Bialystok, 15-756, Poland
Neurocrine Clinical Site
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Bialystok, 15-879, Poland
Neurocrine Clinical Site
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Bydgoszcz, 85-794, Poland
Neurocrine Clinical Site
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Gdansk, 80-283, Poland
Neurocrine Clinical Site
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Gdansk, 80-546, Poland
Neurocrine Clinical Site
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Grudziądz, 86-300, Poland
Neurocrine Clinical Site
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Katowice, 40-514, Poland
Neurocrine Clinical Site
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Craiova, 200157, Romania
Neurocrine Clinical Site
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Bojnice, 97201, Slovakia
Neurocrine Clinical Site
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Bratislava, 820 07, Slovakia
Neurocrine Clinical Site
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Košice, 04001, Slovakia
Neurocrine Clinical Site
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Rimavská Sobota, 979 01, Slovakia
Neurocrine Clinical Site
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Svidník, 089 01, Slovakia
Neurocrine Clinical Site
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Vranov nad Topľou, 093 01, Slovakia
Neurocrine Clinical Site
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Gothenburg, 41345, Sweden
Neurocrine Clinical Site
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Lund, 222 22, Sweden
Neurocrine Clinical Site
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Stockholm, 113 29, Sweden
Neurocrine Clinical Site
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Taipei, 112201, Taiwan
Neurocrine Clinical Site
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Southampton, Hampshire, SO30 3JB, United Kingdom
Neurocrine Clinical Site
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Sheffield, South Yorkshire, S3 7ND, United Kingdom
Neurocrine Clinical Site
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London, SE5 8AF, United Kingdom
Neurocrine Clinical Site
RECRUITING

Manchester, M25 3BL, United Kingdom