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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06966401
The ClinicalTrials.gov registry entry for NCT06966401 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (60% higher). The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.
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 reports 18 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.