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Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RECRUITINGPhase 3Sponsored by Neurocrine Biosciences
Actively Recruiting
PhasePhase 3
SponsorNeurocrine Biosciences
Started2025-04-16
Est. completion2029-05
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations40 sites
View on ClinicalTrials.gov →
NCT06966401
Summary
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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. Other protocol defined inclusion and exclusion criteria apply.
Conditions2
DepressionMajor Depressive Disorder
Interventions1
Locations40 sites
Neurocrine Clinical Site
Huntsville, Alabama, 35801
Neurocrine Clinical Site
Bryant, Arkansas, 72022
Neurocrine Clinical Site
Little Rock, Arkansas, 72204
Neurocrine Clinical Site
Neurocrine Clinical Site
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 3
SponsorNeurocrine Biosciences
Started2025-04-16
Est. completion2029-05
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations40 sites
View on ClinicalTrials.gov →
NCT06966401