Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

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.

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.

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