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A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT07196501

RecruitingPhase 3

Sponsor: Neurocrine Biosciences

Conditions: Major Depressive Disorder

Interventions: NBI-1065845, Placebo

Countries: United States, Australia, Bulgaria, Canada, Estonia, Italy, Poland, Serbia

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

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.

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Locations (60)
  • Oceanside, California, United States
  • Orange, California, United States
  • San Jose, California, United States
  • New Haven, Connecticut, United States
  • Miami Gardens, Florida, United States
  • Orlando, Florida, United States
  • Palm Bay, Florida, United States
  • Tampa, Florida, United States
  • Iowa City, Iowa, United States
  • Marrero, Louisiana, United States
  • O'Fallon, Missouri, United States
  • Albuquerque, New Mexico, United States
  • Glen Oaks, New York, United States
  • Charlotte, North Carolina, United States
  • Edmond, Oklahoma, United States
  • Oklahoma City, Oklahoma, United States
  • Philadelphia, Pennsylvania, United States
  • Austin, Texas, United States
  • Bellaire, Texas, United States
  • Friendswood, Texas, United States
  • Stafford, Texas, United States
  • Wichita Falls, Texas, United States
  • Draper, Utah, United States
  • Roanoke, Virginia, United States
  • Carlton, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Parkville, Victoria, Australia
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • + 30 more on CT.gov