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NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT06963021

RecruitingPhase 3

Sponsor: Neurocrine Biosciences

Conditions: Major Depressive Disorder

Interventions: NBI-1065845, Placebo

Countries: United States, Belgium, Canada, Finland, Hungary, Latvia, United Kingdom

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 (35)
  • Chino, California, United States
  • Los Angeles, California, United States
  • Stanford, California, United States
  • Aurora, Colorado, United States
  • Cromwell, Connecticut, United States
  • Farmington, Connecticut, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Gaithersburg, Maryland, United States
  • Cedarhurst, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Charlotte, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Alken, Belgium
  • Bruges, Belgium
  • Mechelen, Belgium
  • Toronto, Ontario, Canada
  • Verdun, Canada
  • Kuopio, Finland
  • Oulu, Finland
  • Tampere, Finland
  • Budapest, Hungary
  • Budapest, Hungary
  • Budapest, Hungary
  • Gyöngyös, Hungary
  • Kalocsa, Hungary
  • Jelgava, Latvia
  • Liepāja, Latvia
  • + 5 more on CT.gov