New depression pill shows promise in Late-Stage trial

NCT ID NCT06911112

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

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.

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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

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WITHDRAWN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
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Rousse, 7003, Bulgaria
Neurocrine Clinical Site
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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

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