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

Key Inclusion Criteria:

• Participant has a primary diagnosis of recurrent MDD (moderate or severe) orpersistent depressive disorder.

• Participant has had an inadequate response to oral antidepressant treatments in thecurrent episode of depression.

• Participant must have been taking oral antidepressants for at least 8 weeks prior toscreening.

• Willing and able to comply with all study procedures and restrictions in the opinionof the investigator.

Key Exclusion Criteria:

• A current or prior psychiatric disorder diagnosis in the last 1 year that was theprimary focus of treatment other than MDD.

• Are considered by the investigator to be at imminent risk of suicide or injury toself or others.

Other protocol defined inclusion and exclusion criteria apply.