Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
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.
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)
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
Conditions
Interventions
- NBI-1065845 Drug
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
- Apr 22, 2026
2025 – 2030
United States locations
- U.S. sites
- 40
- U.S. states
- 15
- U.S. cities
- 37
| 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 | 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 | 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 | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Neurocrine Clinical Site | Dallas | Texas | 75251 | 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 47 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 Apr 22, 2026 · Synced May 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06966401 live on ClinicalTrials.gov.