A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Public ClinicalTrials.gov record NCT07196501. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07196501
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 550 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 17, 2025
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2028
- Last update posted
- Jul 23, 2026
2025 – 2028
United States locations
- U.S. sites
- 24
- U.S. states
- 14
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neurocrine Clinical Site | Oceanside | California | 92056 | Recruiting |
| Neurocrine Clinical Site | Orange | California | 92868 | Recruiting |
| Neurocrine Clinical Site | San Jose | California | 95124 | Recruiting |
| Neurocrine Clinical Site | New Haven | Connecticut | 06520 | Recruiting |
| Neurocrine Clinical Site | Miami Gardens | Florida | 33014 | Recruiting |
| Neurocrine Clinical Site | Orlando | Florida | 32803 | Recruiting |
| Neurocrine Clinical Site | Palm Bay | Florida | 32905 | Recruiting |
| Neurocrine Clinical Site | Tampa | Florida | 33629 | Recruiting |
| Neurocrine Clinical Site | Iowa City | Iowa | 52242 | Recruiting |
| Neurocrine Clinical Site | Marrero | Louisiana | 70072 | Recruiting |
| Neurocrine Clinical Site | O'Fallon | Missouri | 63368 | Recruiting |
| Neurocrine Clinical Site | Albuquerque | New Mexico | 87109 | Recruiting |
| Neurocrine Clinical Site | Glen Oaks | New York | 11004 | Recruiting |
| Neurocrine Clinical Site | Charlotte | North Carolina | 28211 | Recruiting |
| Neurocrine Clinical Site | Edmond | Oklahoma | 73013 | Recruiting |
| Neurocrine Clinical Site | Oklahoma City | Oklahoma | 73112 | Recruiting |
| Neurocrine Clinical Site | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Neurocrine Clinical Site | Austin | Texas | 78712 | Active, not recruiting |
| Neurocrine Clinical Site | Bellaire | Texas | 77401 | Recruiting |
| Neurocrine Clinical Site | Friendswood | Texas | 77546 | Terminated |
| Neurocrine Clinical Site | Stafford | Texas | 77477 | Recruiting |
| Neurocrine Clinical Site | Wichita Falls | Texas | 76309 | Recruiting |
| Neurocrine Clinical Site | Draper | Utah | 84020 | Recruiting |
| Neurocrine Clinical Site | Roanoke | Virginia | 24018 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07196501, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2026 · Synced Jul 30, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07196501 live on ClinicalTrials.gov.