Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Recruiting now Phase 3 NCT06786624
Run by Neurocrine Biosciences · for 18 and older · All sexes
What this study is about
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
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 and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
- Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- 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.
- Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
Where this trial is running
- Neurocrine Clinical Site, Little Rock, Arkansas, United States
- Neurocrine Clinical Site, Garden Grove, 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, Upland, California, United States
- Neurocrine Clinical Site, Hollywood, Florida, United States
- Neurocrine Clinical Site, Maitland, Florida, United States
- Neurocrine Clinical Site, Boston, Massachusetts, United States
- Neurocrine Clinical Site, Watertown, Massachusetts, United States
- Neurocrine Clinical Site, Mount Kisco, New York, United States
- Neurocrine Clinical Site, Avon Lake, Ohio, United States
+ 6 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: NCT06786624.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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