RecruitingPhase 3NCT06966401
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Sponsor
Neurocrine Biosciences
Enrollment
600 participants
Start Date
Apr 16, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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.
Exclusion Criteria2
- 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.
Interventions
DRUGNBI-1065845
NBI-1065845 tablets
Locations(18)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06966401
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