Project A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and…

Basic data

Title:
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects with Treatment-resistant Depression
Duration:
19/10/2015 to 31/10/2016
Abstract / short description:
The current study is being conducted to evaluate the efficacy, safety, and tolerability of flexibly dosed intranasal esketamine plus a newly initiated oral antidepressant in adult subjects with treatment-resistant depression (TRD). The study will serve as a pivotal Phase 3 short-term efficacy and safety study in support of regulatory agency requirements for registration of intranasal esketamine for the treatment of TRD.
Keywords:
Esketamin (esketamine)
depression
Depression
treatment resistance
Therapieresistenz

Involved staff

Managers

Department of Psychiatry and Psychotherapy
Hospitals and clinical institutes, Faculty of Medicine

Local organizational units

Department of Neurology with Focus on Epileptology
Department of Psychiatry and Psychotherapy
Hospitals and clinical institutes, Faculty of Medicine

Funders

Neuss, Nordrhein-Westfalen, Germany
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