Clinical Trials in Belgium / NCT06966401
Recruiting
Phase 3
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06966401 · tracked via the Priya Life Science Belgium tracker
Condition(s) studied
Major Depressive Disorder
Study summary
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Eligibility
Key Inclusion Criteria:
* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
* Participant must have been taking oral antidepressants for at least 8 weeks prior to screening.
* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
Key Exclusion Criteria:
* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
Other protocol defined inclusion and exclusion criteria apply.
Primary outcome measure(s)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) — Baseline through Week 52
Trial sites (106)
| Facility | City | Region | Status |
|---|---|---|---|
| Neurocrine Clinical Site | Huntsville | Alabama | Recruiting |
| Neurocrine Clinical Site | Bryant | Arkansas | Recruiting |
| Neurocrine Clinical Site | Little Rock | Arkansas | Recruiting |
| Neurocrine Clinical Site | Glendale | California | Recruiting |
| Neurocrine Clinical Site | Los Angeles | California | Recruiting |
| Neurocrine Clinical Site | Oceanside | California | Recruiting |
| Neurocrine Clinical Site | Orange | California | Recruiting |
| Neurocrine Clinical Site | Pico Rivera | California | Recruiting |
| Neurocrine Clinical Site | San Diego | California | Recruiting |
| Neurocrine Clinical Site | San Francisco | California | Recruiting |
| Neurocrine Clinical Site | San Jose | California | Recruiting |
| Neurocrine Clinical Site | Upland | California | Terminated |
| Neurocrine Clinical Site | Cromwell | Connecticut | Recruiting |
| Neurocrine Clinical Site | Farmington | Connecticut | Recruiting |
| Neurocrine Clinical Site | Hollywood | Florida | Recruiting |
| Neurocrine Clinical Site | Maitland | Florida | Recruiting |
| Neurocrine Clinical Site | Maitland | Florida | Recruiting |
| Neurocrine Clinical Site | Miami | Florida | Recruiting |
| Neurocrine Clinical Site | Miami Gardens | Florida | Recruiting |
| Neurocrine Clinical Site | Orlando | Florida | Withdrawn |
| Neurocrine Clinical Site | Palm Bay | Florida | Recruiting |
| Neurocrine Clinical Site | Tampa | Florida | Recruiting |
| Neurocrine Clinical Site | Tampa | Florida | Recruiting |
| Neurocrine Clinical Site | Atlanta | Georgia | Recruiting |
| Neurocrine Clinical Site | Gaithersburg | Maryland | Recruiting |
| Neurocrine Clinical Site | Boston | Massachusetts | Recruiting |
| Neurocrine Clinical Site | Watertown | Massachusetts | Recruiting |
| Neurocrine Clinical Site | O'Fallon | Missouri | Recruiting |
| Neurocrine Clinical Site | Saint Charles | Missouri | Recruiting |
| Neurocrine Clinical Site | Cedarhurst | New York | Recruiting |
| Neurocrine Clinical Site | Mount Kisco | New York | Recruiting |
| Neurocrine Clinical Site | New York | New York | Recruiting |
| Neurocrine Clinical Site | New York | New York | Recruiting |
| Neurocrine Clinical Site | The Bronx | New York | Recruiting |
| Neurocrine Clinical Site | Avon Lake | Ohio | Recruiting |
| Neurocrine Clinical Site | Edmond | Oklahoma | Recruiting |
| Neurocrine Clinical Site | Oklahoma City | Oklahoma | Withdrawn |
| Neurocrine Clinical Site | Philadelphia | Pennsylvania | Recruiting |
| Neurocrine Clinical Site | Bellaire | Texas | Recruiting |
| Neurocrine Clinical Site | Dallas | Texas | Recruiting |
+ 66 more sites — see the full list on the official registry below.
More Neurocrine Biosciences trials in Belgium
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06966401 on ClinicalTrials.gov ↗ ← All trials in Belgium