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A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT07196501 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NBI-1065845
Study Locations (20)
Florida
- Neurocrine Clinical Site — Miami Gardens
- Neurocrine Clinical Site — Orlando
- Neurocrine Clinical Site — Palm Bay
- Neurocrine Clinical Site — Tampa
Texas
- Neurocrine Clinical Site — Bellaire
- Neurocrine Clinical Site — Friendswood
- Neurocrine Clinical Site — Stafford
- Neurocrine Clinical Site — Wichita Falls
California
- Neurocrine Clinical Site — Oceanside
- Neurocrine Clinical Site — San Jose
Oklahoma
- Neurocrine Clinical Site — Edmond
- Neurocrine Clinical Site — Oklahoma City
Connecticut
- Neurocrine Clinical Site — New Haven
Louisiana
- Neurocrine Clinical Site — Marrero
Missouri
- Neurocrine Clinical Site — O'Fallon
New Mexico
- Neurocrine Clinical Site — Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2025-08-18 |
| Est. Completion | 2028-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07196501
The ClinicalTrials.gov registry entry for NCT07196501 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 550 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 2 interventions — of which Placebo 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: NCT07196501 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Texas, California. 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 NCT07196501 about?
NCT07196501 is a clinical study titled "A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)". The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.
What is the current status of trial NCT07196501?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2025-08-18. Estimated completion is 2028-07.
What conditions does trial NCT07196501 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 NCT07196501?
The interventions under investigation include: Placebo (DRUG), NBI-1065845 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07196501?
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 NCT07196501 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Louisiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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