Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (47% lower). 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 2 interventions - of which Placebo is the first listed.
NCT06963021 reports 16 study locations spanning 7 distinct geographic areas - top geographies include 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.
-
A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RECRUITING · Phase 3
-
Study to Assess the Safety and Effectiveness of NMRA-335140-501
RECRUITING · Phase 3
-
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RECRUITING · Phase 3
-
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder
RECRUITING · Phase 3
-
"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
RECRUITING · Phase 3
-
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RECRUITING · Phase 3
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.