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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 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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (47% higher). 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.
NCT07196501 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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