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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
NBI-1065845
DrugNBI-1065845 tablets
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Sponsors and contacts
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