Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Recruiting now Phase 3 NCT06966401
Run by Neurocrine Biosciences · for 18 and older · All sexes
What this study is about
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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.
🚫 You may not be able to join if…
- 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.
Where this trial is running
- Neurocrine Clinical Site, Huntsville, Alabama, United States
- Neurocrine Clinical Site, Bryant, Arkansas, United States
- Neurocrine Clinical Site, Little Rock, Arkansas, United States
- Neurocrine Clinical Site, Glendale, California, United States
- Neurocrine Clinical Site, Los Angeles, California, United States
- Neurocrine Clinical Site, Oceanside, California, United States
- Neurocrine Clinical Site, Orange, California, United States
- Neurocrine Clinical Site, Pico Rivera, California, United States
- Neurocrine Clinical Site, San Diego, California, United States
- Neurocrine Clinical Site, San Francisco, California, United States
- Neurocrine Clinical Site, Upland, California, United States
- Neurocrine Clinical Site, Cromwell, Connecticut, United States
+ 86 more sites.
Who to contact
Neurocrine Medical Information Call Center · 1-877-641-3461 · medinfo@neurocrine.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06966401.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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