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Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06966401 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurocrine Biosciences, which has 47 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06966401 reports 18 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06966401?
The interventions under investigation include: NBI-1065845 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06966401?
This trial is sponsored by Neurocrine Biosciences, which has 47 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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