- CSR Summary CSR(s) for this product are publicly available on Health Canada’s website - https://clinical-information.canada.ca/search/ci-rc
- NCT01998958
- Primary Citation
- Data Specification Not Available
Trial Information
Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaBehaviors and Mental DisordersEnrollment108% Female50.9%% White44.4%
Product ClassNMDA receptor antagonistSponsor Protocol NumberESKETINTRD2003Data PartnerJohnson & JohnsonCondition StudiedDepressive Disorder, Treatment-ResistantMean/Median Age (Years)44.6
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
- 2024-0612 : Effects of ketamine and esketamine on death, suicidal behavior and suicidal ideation in psychiatric disorders: A systematic review and meta-analysis
- 2023-5241 : Cognitive effects of repeated-dose Ketamine in the treatment of major depression: a systematic review and individual patient data meta-analysis.
- 2023-5230 : Esketamine for treatment-resistant depression in adults: Cochrane systematic review and meta-analysis on efficacy and tolerability of esketamine
- 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
- 2021-4835 : Role of clinical, historical and demographic factors in the response to antidepressants versus placebo
- 2021-4658 : Ketamine for the treatment of major depression: a systematic review and meta-analysis
- 2019-3958 : Machine Learning for predicting treatment efficacy and clinical categorizations across mental health disorders.