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Trial Information
Generic NameTopiramateProduct NameTOPAMAX®Therapeutic AreaNervous SystemProduct ClassAntiepilepticsPharmacological SubgroupAntiepilepticsChemical SubgroupOther AntiepilepticsCondition StudiedBipolar Disorder
Sponsor Protocol NumberCR002653 (CAPSS-168)Enrollment287Data PartnerJohnson & Johnson% Female56.4%Mean/Median Age (Years)40.0% White84.0%
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
- 2022-5090 : Consistency checks to improve measurement with the Young Mania Rating Scale (YMRS)
- 2022-5062 : Heterogeneous treatment effects estimation with multi-source data: evidence from bipolar disorder and schizophrenia trials
- 2020-4521 : Causally interpretable meta-analysis with missing data: Generalizing evidence from bipolar disorder and schizophrenia trials to a target population
- 2020-4276 : Psychiatric Symptoms as Adverse Events of Topiramate Therapy: Systematic Review and Meta-Analysis
- 2019-3958 : Machine Learning for predicting treatment efficacy and clinical categorizations across mental health disorders.
- 2015-0644 : Generalizing treatment effects for bipolar disorder and schizophrenia to the US population: Generalizability of network meta-analysis