Clinical Trials in the UK / 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 UK 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 the UK
Other trials for the same condition
ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression
Active, not recruiting
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
Enrolling by invitation
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 the UK