- CSR Summary Not Yet Available
- NCT02417064
- Primary Citation
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Trial Information
Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaBehaviors and Mental DisordersEnrollment346% Female70.3%% White76.5%
Product ClassNMDA receptor antagonistSponsor Protocol NumberESKETINTRD3001Data PartnerJohnson & JohnsonCondition StudiedDepressive Disorder, MajorMean/Median Age (Years)46.3
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
- 2023-5241 : 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
- 2021-4818 : Rapidity of Symptom Improvement with Intranasal Esketamine for Major Depressive Disorder: A Systematic Review and Meta-analysis
- 2021-4758 : Examining the relationship between esketamine-induced dissociation and antidepressant effects
- 2021-4658 : Ketamine for the treatment of major depression: 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.