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NCT06963021 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Major Depressive Disorder, sponsored by Neurocrine Biosciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 16
- Study locations
NCT06963021: Recruiting Phase 3 study of Major Depressive Disorder, sponsored by Neurocrine Biosciences.
NCT06963021 is a Phase 3 study of Major Depressive Disorder that is actively recruiting participants, run by Neurocrine Biosciences. The registered enrollment target is 200 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (47% lower). The trial reports 16 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06963021, a Phase 3 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Neurocrine Biosciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 16
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-05-30 |
| Est. Completion | 2027-07 |
| Phase | Phase 3 |
What NCT06963021 shows while recruiting
NCT06963021 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (47% lower).
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.
NCT06963021 lists 16 locations in 7 states (Other, New York, Connecticut).
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.
What interventions are being tested in trial NCT06963021?
The interventions under investigation include: Placebo (DRUG), NBI-1065845 (DRUG).
Who is sponsoring clinical trial NCT06963021?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT06963021's enrollment target sits among peer trials
200 74th of 282 higher than 203 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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