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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeurocrine Biosciences

About this trial

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • NBI-1065845

Treatment groups

850 Participants
are divided into 1 treatment group

Sponsors and collaborators