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RECRUITING Phase 3

NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT06963021 · View on ClinicalTrials.gov ↗

Study Summary

The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG NBI-1065845

Study Locations (16)

Other

  • Neurocrine Clinical Site — Alken
  • Neurocrine Clinical Site — Mechelen
  • Neurocrine Clinical Site — Oulu
  • Neurocrine Clinical Site — Jelgava
  • Neurocrine Clinical Site — Liepāja
  • Neurocrine Clinical Site — Sigulda

New York

  • Neurocrine Clinical Site — Cedarhurst
  • Neurocrine Clinical Site — New York
  • Neurocrine Clincial Site — New York

Connecticut

  • Neurocrine Clinical Site — Cromwell
  • Neurocrine Clinical Site — Farmington

Florida

  • Neurocrine Clinical Site — Maitland
  • Neurocrine Clinical Site — Tampa

California

  • Neurocrine Clinical Site — Los Angeles

Colorado

  • Neurocrine Clinical Site — Aurora

Maryland

  • Neurocrine Clinical Site — Gaithersburg

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2025-05-30
Est. Completion 2027-07
Phase Phase 3

Sponsor

Neurocrine Biosciences

47 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06963021

The ClinicalTrials.gov registry entry for NCT06963021 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 200 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: NCT06963021 reports 16 study locations spanning 7 distinct geographic areas — top geographies include Other, New York, Connecticut. 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 NCT06963021 about?

NCT06963021 is a clinical study titled "NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)". The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.

What is the current status of trial NCT06963021?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2025-05-30. Estimated completion is 2027-07.

What conditions does trial NCT06963021 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 NCT06963021?

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 NCT06963021?

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 NCT06963021 being conducted?

This trial has 16 study locations across California, Colorado, Connecticut, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial