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NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT06911112

RecruitingPhase 3

Sponsor: Neurocrine Biosciences

Conditions: Major Depressive Disorder

Interventions: NBI-1065845, Placebo

Countries: United States, Bulgaria, Lithuania, Romania, Slovakia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 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.

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.
* Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
Locations (39)
  • Huntsville, Alabama, United States
  • Bryant, Arkansas, United States
  • Glendale, California, United States
  • Irvine, California, United States
  • Redlands, California, United States
  • San Francisco, California, United States
  • Hollywood, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Boston, Massachusetts, United States
  • Saint Charles, Missouri, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Mason, Ohio, United States
  • DeSoto, Texas, United States
  • Charlottesville, Virginia, United States
  • Kardzhali, Bulgaria
  • Plovdiv, Bulgaria
  • Rousse, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Varna, Bulgaria
  • Kaunas, Lithuania
  • Kaunas, Lithuania
  • Kaunas, Lithuania
  • Klaipėda, Lithuania
  • Vilnius, Lithuania
  • Bucharest, Romania
  • Bucharest, Romania
  • + 9 more on CT.gov