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Clinical trial

54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide

Janssen Research & Development, LLCCompletedPhase 3Started Jun 9, 2017226 enrolledUnited States, Bulgaria, Estonia, Germany, Hungary, Malaysia, Slovakia, South Africa, South Korea, Spain, TaiwanNCT03039192

Abstract

The purpose of the study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.

Topics & conditions

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KetamineDepression

Keywords

Depressive Disorder, Major

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