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CSR Summary
Not Yet Available
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NCT04338321
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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 Number54135419TRD3013Enrollment676Data PartnerJohnson & Johnson% Female66.1%Mean/Median Age (Years)45.0% White42.8%
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
- 2025-0884 : Personalized Ketamine Dosing: A Population PK/Pharmacogenomic Model Using Participant-Level Esketamine Trial Data
- 2025-0756 : Multi-Analyst Reanalysis of IPD on Esketamine and Suicidality (Team Three)
- 2025-0752 : Multi-Analyst Reanalysis of IPD on Esketamine and Suicidality (Team Two)
- 2025-0748 : Multi-Analyst Reanalysis of IPD on Esketamine and Suicidality (Team One)
