Phenomics & Genomics of Clozapine Pharmacotherapy: To a better understanding of the backgrounds of clozapine use
Recruiting
- Conditions
- Genetics of clozapine use because of schizophrenia, schizo-affective disorder, schizophreniform disorder
- Registration Number
- NL-OMON20386
- Lead Sponsor
- Dr. J. Luykx
- Brief Summary
one yet
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2500
Inclusion Criteria
he/she currently uses CLZ
-he/she has received a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis not otherwise specified
Exclusion Criteria
- admission to a psychiatric unit involuntarily in the context of an ‘inbewaringstelling’ (IBS)
- a history of Parkinson’s disease
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method First, in a discovery cohort a case-control genome-wide association study (GWAS) will be performed on 2000 CLZ using subjects (cases) and >30,000 already available SCZ patients (controls, drawn from the most recent Psychiatric Genomics Consortium analysis, . We hereby aim to reveal potential differences in the genetic architecture between the severe CLZ-SCZ phenotype and the broad SCZ phenotype.
- Secondary Outcome Measures
Name Time Method Second, a replication cohort of the same size as the discovery cohort (N=2,000 CLZ using subjects and the same number of controls) will be used to replicate any positive associations for each of the two GWAS analyses.<br>Should funding allow and if replication cohorts are available elsewhere and possibly for the purpose of participation in large-scale consortia, GWAS and NGS may be performed on >2,000 CLZ users, e.g. the entire study population.<br>In addition, we use the data with our other protocol (NTR 5257) to create a prediction model for clozapine response and side effects.