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Phenomics & Genomics of Clozapine Pharmacotherapy: To a better understanding of the backgrounds of clozapine use

Phenomics & Genomics of Clozapine Pharmacotherapy: Current Users

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20386
Enrollment
2500
Registered
2015-06-11
Start date
2015-07-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetics of clozapine use because of schizophrenia, schizo-affective disorder, schizophreniform disorder

Interventions

None

Sponsors

Dr. J. Luykx
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -he/she currently uses CLZ -he/she has received a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis not otherwise specified -his/her age must be ≥18 years old -he/she must be able to speak and read the Dutch language -he/she must be mentally competent and have decisional capacity with regard to a decision to participate in the current study

Exclusion criteria

Exclusion criteria: - admission to a psychiatric unit involuntarily in the context of an ‘inbewaringstelling’ (IBS) - a history of Parkinson’s disease

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 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. In addition, we use the data with our other protocol (NTR 5257) to create a prediction model for clozapine response and side effects.

Contacts

Public ContactMarte van der Horst

UMCU A01.126

mzvanderhorst@gmail.com0887551460

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)