- CSR Summary CSR(s) for this product are publicly available on Health Canada’s website - https://clinical-information.canada.ca/search/ci-rc
- NCT03039192
- Primary Citation
- Data Specification Not Available
Trial Information
Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaBehaviors and Mental DisordersEnrollment226% Female61.8%% White67.1%
Product ClassNMDA receptor antagonistSponsor Protocol Number54135419SUI3001Data PartnerJohnson & JohnsonCondition StudiedDepressive Disorder, MajorMean/Median Age (Years)39.3
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0620 : Placebo Prediction in Major Depressive Disorder Using AI/ML
- 2024-0612 : Effects of ketamine and esketamine on death, suicidal behavior and suicidal ideation in psychiatric disorders: A systematic review and meta-analysis
- 2023-5220 : Association between the reduction of Suicidal ideation, Anhedonia and Psychological pain in patients treated by intranasal esketamine