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Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT06966401

RecruitingPhase 3

Sponsor: Neurocrine Biosciences

Conditions: Major Depressive Disorder

Interventions: NBI-1065845

Countries: United States, Belgium, Bulgaria, Canada, Croatia, Czechia, Estonia, Finland

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment 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 prior to screening.
* 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.

Other protocol defined inclusion and exclusion criteria apply.
Locations (106)
  • Huntsville, Alabama, United States
  • Bryant, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Glendale, California, United States
  • Los Angeles, California, United States
  • Oceanside, California, United States
  • Orange, California, United States
  • Pico Rivera, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • San Jose, California, United States
  • Upland, California, United States
  • Cromwell, Connecticut, United States
  • Farmington, Connecticut, United States
  • Hollywood, Florida, United States
  • Maitland, Florida, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Miami Gardens, Florida, United States
  • Orlando, Florida, United States
  • Palm Bay, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Gaithersburg, Maryland, United States
  • Boston, Massachusetts, United States
  • Watertown, Massachusetts, United States
  • O'Fallon, Missouri, United States
  • Saint Charles, Missouri, United States
  • Cedarhurst, New York, United States
  • + 76 more on CT.gov