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Recruiting Phase 3 Interventional

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

ClinicalTrials.gov ID: NCT06966401

Public ClinicalTrials.gov record NCT06966401. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 10:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT06966401
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Neurocrine Biosciences
Industry
Enrollment
850 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 15, 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2030
Last update posted
Jul 23, 2026

2025 – 2030

United States locations

U.S. sites
46
U.S. states
15
U.S. cities
43
Facility City State ZIP Site status
Neurocrine Clinical Site Huntsville Alabama 35801 Recruiting
Neurocrine Clinical Site Bryant Arkansas 72022 Recruiting
Neurocrine Clinical Site Little Rock Arkansas 72204 Recruiting
Neurocrine Clinical Site Glendale California 91206 Recruiting
Neurocrine Clinical Site Los Angeles California 90025 Recruiting
Neurocrine Clinical Site Oceanside California 92056 Recruiting
Neurocrine Clinical Site Orange California 92866 Recruiting
Neurocrine Clinical Site Pico Rivera California 90660 Recruiting
Neurocrine Clinical Site San Diego California 92103-8229 Recruiting
Neurocrine Clinical Site San Francisco California 94107 Recruiting
Neurocrine Clinical Site San Jose California 95124 Recruiting
Neurocrine Clinical Site Upland California 91786 Terminated
Neurocrine Clinical Site Cromwell Connecticut 06416 Recruiting
Neurocrine Clinical Site Farmington Connecticut 06030 Recruiting
Neurocrine Clinical Site Hollywood Florida 33024 Recruiting
Neurocrine Clinical Site Maitland Florida 32751-5669 Recruiting
Neurocrine Clinical Site Maitland Florida 32751 Recruiting
Neurocrine Clinical Site Miami Florida 33174 Recruiting
Neurocrine Clinical Site Miami Gardens Florida 33014 Recruiting
Neurocrine Clinical Site Orlando Florida 32803 Withdrawn
Neurocrine Clinical Site Palm Bay Florida 32905 Recruiting
Neurocrine Clinical Site Tampa Florida 33607 Recruiting
Neurocrine Clinical Site Tampa Florida 33629 Recruiting
Neurocrine Clinical Site Atlanta Georgia 30318 Recruiting
Neurocrine Clinical Site Gaithersburg Maryland 20877 Recruiting
Neurocrine Clinical Site Boston Massachusetts 02116 Recruiting
Neurocrine Clinical Site Watertown Massachusetts 02472 Recruiting
Neurocrine Clinical Site O'Fallon Missouri 63368 Recruiting
Neurocrine Clinical Site Saint Charles Missouri 63304 Recruiting
Neurocrine Clinical Site Cedarhurst New York 11516 Recruiting
Neurocrine Clinical Site Mount Kisco New York 10549 Recruiting
Neurocrine Clinical Site New York New York 10029 Recruiting
Neurocrine Clinical Site New York New York 10128 Recruiting
Neurocrine Clinical Site The Bronx New York 10461 Recruiting
Neurocrine Clinical Site Avon Lake Ohio 44012 Recruiting
Neurocrine Clinical Site Edmond Oklahoma 73013 Recruiting
Neurocrine Clinical Site Oklahoma City Oklahoma 73112 Withdrawn
Neurocrine Clinical Site Philadelphia Pennsylvania 19104 Recruiting
Neurocrine Clinical Site Bellaire Texas 77401 Recruiting
Neurocrine Clinical Site Dallas Texas 75251 Recruiting
Neurocrine Clinical Site DeSoto Texas 75115 Recruiting
Neurocrine Clinical Site Houston Texas 77030 Recruiting
Neurocrine Clinical Site Richmond Texas 77407 Withdrawn
Neurocrine Clinical Site Stafford Texas 77477 Recruiting
Neurocrine Clinical Site The Woodlands Texas 77381 Recruiting
Neurocrine Clinical Site Everett Washington 98201 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 59 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06966401, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 23, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06966401 live on ClinicalTrials.gov.

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