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A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

RecruitingPhase 3Ages 18 Years - anyAllNeurocrine Biosciences
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In plain words

What the trial is, and whether it could suit you

The primary objective of this study is to evaluate the efficacy of osavampator (previously NBI-1065845) compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study. * Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score โ‰ฅ22 at screening and at study baseline (Day 1). * 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. * Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
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What it tests

  • Osavampator
  • Placebo
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Where

61 sites
Neurocrine Clinical Site
Oceanside, United States
Neurocrine Clinical Site
Orange, United States
Neurocrine Clinical Site
San Jose, United States
Neurocrine Clinical Site
New Haven, United States
Neurocrine Clinical Site
Miami Gardens, United States
Neurocrine Clinical Site
Orlando, United States
Neurocrine Clinical Site
Palm Bay, United States
Neurocrine Clinical Site
Tampa, United States

โ€ฆand 53 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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