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NCT07196501 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Maintenance Effect 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
- 550
- Enrollment target
- 20
- Study locations
NCT07196501: Recruiting Phase 3 study of Major Depressive Disorder, sponsored by Neurocrine Biosciences.
NCT07196501 is a Phase 3 study of Major Depressive Disorder that is actively recruiting participants, run by Neurocrine Biosciences. The registered enrollment target is 550 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07196501, a Phase 3 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Neurocrine Biosciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 550 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT07196501 shows while recruiting
NCT07196501 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (47% higher).
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.
NCT07196501 names 20 study sites across 12 states, led by Florida, Texas, California.
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.
What interventions are being tested in trial NCT07196501?
The interventions under investigation include: Placebo (DRUG), NBI-1065845 (DRUG).
Who is sponsoring clinical trial NCT07196501?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT07196501's enrollment target sits among peer trials
550 27th of 282 higher than 256 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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Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
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