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NCT03039192 - A Double-blind, Randomized, Placebo-controlled 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

A Double-blind, Randomized, Placebo-controlled 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 Subjects Assessed to be at Imminent Risk for Suicide


CSR Summary

Not Available


Data Specification

Available upon data request approval


Annotated CRF

Available upon data request approval

Product Info

Generic Name
Esketamine
Product Name
SPRAVATO®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
226
% Female
61.8%
% White
67.1%
Product Class
NMDA receptor antagonist
Sponsor Protocol Number
54135419SUI3001
Data Partner
Johnson & Johnson
Condition Studied
Depressive Disorder, Major
Mean/Median Age (Years)
39.3

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.