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CSR Summary
CSR(s) for this product are publicly available on Health Canada's website - https://clinical-information.canada.ca/search/ci-rc
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NCT02493868
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Primary Citation
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Trial Information
Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaNervous SystemProduct ClassPsychoanalepticsPharmacological SubgroupAntidepressantsChemical SubgroupOther AntidepressantsCondition StudiedDepressive Disorder, Major
Sponsor Protocol NumberESKETINTRD3003Enrollment719Data PartnerJohnson & Johnson% Female64.8%Mean/Median Age (Years)46.1% White79.7%
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
- 2025-0352 : ALL-EMBRACED: clinicAL triaLs web-sErvice to Modify eligiBility cRiteria and pre-screening viA artifiCial intElligence methoDs
- 2025-0004 : Differential Effects of Esketamine on Individual Symptoms of Major Depression
- 2023-5534 : Quality tolerance limit and duplicated patient investigation in clinical trials
- 2023-5354 : Effectiveness of Intranasal Esketamine in Treatment of Patients with Treatment Resistant Depression: An Observational Study on Spravato Treatment
- 2023-5149 : Sex Differences in the Antidepressant Effects of Ketamine
- 2021-4851 : Efficacy of esketamine for "treatment resistant depression" assessed by MADRS score after at least 4 weeks, an IPD meta-analysis
- 2021-4844 : Clinical predictors of antidepressant response to ketamine and esketamine: A systematic review and meta-analysis
- 2021-4637 : Data-sharing and re-analysis for main studies assessed by the European Medicines Agency - a cross-sectional study on EPARs
- 2019-3958 : Machine Learning for predicting treatment efficacy and clinical categorizations across mental health disorders.