A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT07196501
- Run by
- Neurocrine Biosciences
- People needed
- 550
- Starts
- 2025-08-18
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Neurocrine Clinical Site — Melbourne, Victoria, Australia (enrolling)
- Neurocrine Clinical Site — San Jose, California, United States (enrolling)
- Neurocrine Clinical Site — Orange, California, United States (enrolling)
- Neurocrine Clinical Site — Oceanside, California, United States (enrolling)
- Neurocrine Clinical Site — Orlando, Florida, United States (enrolling)
- Neurocrine Clinical Site — Palm Bay, Florida, United States (enrolling)
- Neurocrine Clinical Site — Tampa, Florida, United States (enrolling)
- Neurocrine Clinical Site — New Haven, Connecticut, United States (enrolling)
- Neurocrine Clinical Site — Miami Gardens, Florida, United States (enrolling)
- Neurocrine Clinical Site — O'Fallon, Missouri, United States (enrolling)
- Neurocrine Clinical Site — Albuquerque, New Mexico, United States (enrolling)
- Neurocrine Clinical Site — Glen Oaks, New York, United States (enrolling)
- Neurocrine Clinical Site — Charlotte, North Carolina, United States (enrolling)
- Neurocrine Clinical Site — Edmond, Oklahoma, United States (enrolling)
- Neurocrine Clinical Site — Oklahoma City, Oklahoma, United States (enrolling)
- Neurocrine Clinical Site — Philadelphia, Pennsylvania, United States (enrolling)
- Neurocrine Clinical Site — Iowa City, Iowa, United States (enrolling)
- Neurocrine Clinical Site — Bellaire, Texas, United States (enrolling)
- Neurocrine Clinical Site — Marrero, Louisiana, United States (enrolling)
- Neurocrine Clinical Site — Stafford, Texas, United States (enrolling)
- Neurocrine Clinical Site — Wichita Falls, Texas, United States (enrolling)
- Neurocrine Clinical Site — Draper, Utah, United States (enrolling)
- Neurocrine Clinical Site — Roanoke, Virginia, United States (enrolling)
- Neurocrine Clinical Site — Carlton, Victoria, Australia (enrolling)
- Neurocrine Clinical Site — Parkville, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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