Recruiting
Phase 3

NBI-1065845

Sponsor:

Neurocrine Biosciences

Code:

NCT06966401

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NBI-1065845

Study Details

Brief summary:

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Conditions

Major Depressive Disorder

Study ID

NCT06966401

Start date

Apr 16, 2025

Status verified date

Jul, 2026

Completion date

May, 2030

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 prior to screening.
  • 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.

Other protocol defined inclusion and exclusion criteria apply.

Study Design

Enrollment

850 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NBI-1065845

NBI-1065845 administered orally once a day.

Interventions

NBI-1065845

NBI-1065845 tablets

Primary outcome measure

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline through Week 52 ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

1-877-641-3461medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

Huntsville, Alabama, United States, 35801

Neurocrine Clinical Site

Recruiting

Bryant, Arkansas, United States, 72022

Neurocrine Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72204

Neurocrine Clinical Site

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Glendale, California, United States, 91206

Neurocrine Clinical Site

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Los Angeles, California, United States, 90025

Neurocrine Clinical Site

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Oceanside, California, United States, 92056

Neurocrine Clinical Site

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Orange, California, United States, 92866

Neurocrine Clinical Site

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Pico Rivera, California, United States, 90660

Neurocrine Clinical Site

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San Diego, California, United States, 92103-8229

Neurocrine Clinical Site

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San Francisco, California, United States, 94107

Neurocrine Clinical Site

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San Jose, California, United States, 95124

Neurocrine Clinical Site

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Cromwell, Connecticut, United States, 06416

Neurocrine Clinical Site

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Farmington, Connecticut, United States, 06030

Neurocrine Clinical Site

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Hollywood, Florida, United States, 33024

Neurocrine Clinical Site

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Maitland, Florida, United States, 32751-5669

Neurocrine Clinical Site

Recruiting

Maitland, Florida, United States, 32751

Neurocrine Clinical Site

Recruiting

Miami, Florida, United States, 33174

Neurocrine Clinical Site

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Miami Gardens, Florida, United States, 33014

Neurocrine Clinical Site

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Palm Bay, Florida, United States, 32905

Neurocrine Clinical Site

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Tampa, Florida, United States, 33607

Neurocrine Clinical Site

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Tampa, Florida, United States, 33629

Neurocrine Clinical Site

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Atlanta, Georgia, United States, 30318

Neurocrine Clinical Site

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Gaithersburg, Maryland, United States, 20877

Neurocrine Clinical Site

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Boston, Massachusetts, United States, 02116

Neurocrine Clinical Site

Recruiting

Watertown, Massachusetts, United States, 02472

Neurocrine Clinical Site

Recruiting

O'Fallon, Missouri, United States, 63368

Neurocrine Clinical Site

Recruiting

Saint Charles, Missouri, United States, 63304

Neurocrine Clinical Site

Recruiting

Cedarhurst, New York, United States, 11516

Neurocrine Clinical Site

Recruiting

Mount Kisco, New York, United States, 10549

Neurocrine Clinical Site

Recruiting

New York, New York, United States, 10029

Neurocrine Clinical Site

Recruiting

New York, New York, United States, 10128

Neurocrine Clinical Site

Recruiting

The Bronx, New York, United States, 10461

Neurocrine Clinical Site

Recruiting

Avon Lake, Ohio, United States, 44012

Neurocrine Clinical Site

Recruiting

Edmond, Oklahoma, United States, 73013

Neurocrine Clinical Site

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Philadelphia, Pennsylvania, United States, 19104

Neurocrine Clinical Site

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Bellaire, Texas, United States, 77401

Neurocrine Clinical Site

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Dallas, Texas, United States, 75251

Neurocrine Clinical Site

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DeSoto, Texas, United States, 75115

Neurocrine Clinical Site

Recruiting

Houston, Texas, United States, 77030

Neurocrine Clinical Site

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Stafford, Texas, United States, 77477

Neurocrine Clinical Site

Recruiting

The Woodlands, Texas, United States, 77381

Neurocrine Clinical Site

Recruiting

Everett, Washington, United States, 98201

Neurocrine Clinical Site

Recruiting

Toronto, Ontario, Canada, M5H 1A1

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • MDD
  • Depression
  • Major Depressive Disorder
  • NBI-1065845
  • TAK-653

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2026-07-24.