Interventional, randomised, double-blind, parallel-group study of the efficacy and safety of initial administration of 17 mg vortioxetine intravenously with 10 mg/day vortioxetine orally in patients with Major Depressive Disorder

H. Lundbeck A/S0 个研究点目标入组 54 人开始时间: 2016年7月4日最近更新: 2017年5月29日

适应症

试验速览

暂无简介。

•The patient has recurrent Major Depressive Disorder (MDD), diagnosed according to Diagnostic and Statistical Manual for Mental Disorders, 5th Edition (DSM-5™), classification code (296.3x). The recurrent Major Depressive Episode (MDE) should be confirmed using the Mini-International Neuropsychiatric Interview (MINI).
•The patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score =30 at both Screening and Baseline Visits.
•The patient has had the current MDE for =3 months
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 54
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•The patient has any current psychiatric disorder or Axis I disorder (DSM-5™criteria), other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI).
•The patient has a current diagnosis of history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-5™ criteria).
•The patient suffers from personality disorders, intellectual disability, pervasive development disorder, attention deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-5™criteria).
•The patient has a history of lack of response to previous treatment with vortioxetine (including current episode).
•Other Protocol defined inclusion and exclusion criteria may apply

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