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NCT06966401 · ClinicalTrials.gov registry record · Phase 3
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Phase 3 study of Major Depressive Disorder, sponsored by Neurocrine Biosciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 18
- Study locations
NCT06966401: Recruiting Phase 3 study of Major Depressive Disorder, sponsored by Neurocrine Biosciences.
NCT06966401 is a Phase 3 study of Major Depressive Disorder that is actively recruiting participants, run by Neurocrine Biosciences. The registered enrollment target is 600 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (60% higher). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06966401, a Phase 3 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Neurocrine Biosciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 18
- Study locations
Study Summary
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Conditions Studied
Interventions
- DRUG NBI-1065845
Study Locations (18)
California
- Neurocrine Clinical Site - Orange
- Neurocrine Clinical Site - Pico Rivera
- Neurocrine Clinical Site - Upland
Florida
- Neurocrine Clinical Site - Hollywood
- Neurocrine Clinical Site - Maitland
- Neurocrine Clinical Site - Tampa
Texas
- Neurocrine Clinical Site - Dallas
- Neurocrine Clinical Site - Richmond
- Neurocrine Clinical Site - The Woodlands
Massachusetts
- Neurocrine Clinical Site - Boston
- Neurocrine Clinical Site - Watertown
New York
- Neurocrine Clinical Site - Mount Kisco
- Neurocrine Clinical Site - The Bronx
Arkansas
- Neurocrine Clinical Site - Little Rock
Georgia
- Neurocrine Clinical Site - Atlanta
Missouri
- Neurocrine Clinical Site - Saint Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2025-04-16 |
| Est. Completion | 2030-05 |
| Phase | Phase 3 |
What NCT06966401 shows while recruiting
NCT06966401 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (60% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which NBI-1065845 is the first listed.
NCT06966401 lists 18 locations in 10 states (California, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT06966401 about?
NCT06966401 is a clinical study titled "Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)". This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
What is the current status of trial NCT06966401?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2025-04-16. Estimated completion is 2030-05.
What conditions does trial NCT06966401 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT06966401?
The interventions under investigation include: NBI-1065845 (DRUG).
Who is sponsoring clinical trial NCT06966401?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06966401 being conducted?
This trial has 18 study locations across Arkansas, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06966401's enrollment target sits among peer trials
600 22nd of 282 higher than 260 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
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NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
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