Genotype-Based Carbamazepine Therapy (GENCAT) study

Not Applicable

• Conditions: Epilepsy (partial seizure), schizophrenia, bipolar disorder, trigeminal neuralgia

• Registration Number: JPRN-UMIN000006795
• Lead Sponsor: RIKE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-01
• Study Completion: 2014-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with a history of skin rash induced by carbamazepine. 2) Pregnancy and lactation patients 3) Patients with severe renal failure (serum creatinine>=2.5 mg/dL, or patients on hemodialysis) 4) Patients with cirrhosis 5) Patients with hypoproteinemia (serum albumin<=2.5 g/dL) 6) Patient who are incapable to understand the contents of this study and will not give informed consent 7) Patients who participate in other clinical studies 8) Patients judged by investigators as ineligible for study enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of drug-induced skin rash. 1) Stevens-Johnson syndrome (SJS) 2) Toxic epidermal necrolysis (TEN) 3) Drug-induced hypersensitivity syndrome (DIHS) 4) Maculopapular eruption (MPE) 5) Erythema multiforme (EM) 6) Fixed drug eruption (FDE)

Secondary Outcome Measures

Name	Time	Method
Incidence of other adverse events. 1) Fever 2) Sore throat 3) Fatigue 4) Dizziness 5) Insomnia 6) Gastrointestinal symptoms (asitia, obstipation, diarrhea, xerostomia, nausea, vomiting)