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


- candidate number22330
- NTR NumberNTR5248
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jun-2015
- Secondary IDsABR: NL52726.041.15 
- Public TitlePhenomics & Genomics of Clozapine Pharmacotherapy: To a better understanding of the backgrounds of clozapine use
- Scientific TitlePhenomics & Genomics of Clozapine Pharmacotherapy: Current Users
- ACRONYMCLOZIN Current
- hypothesisTo assess whether the genetic architecture of this severe therapy-resistant SCZ phenotype differs from the broad DSM-based SCZ phenotype.
- Healt Condition(s) or Problem(s) studiedSchizoaffective disorder, Schizophrenia, Schizophreniform disorder
- Inclusion criteria-he/she currently uses CLZ
-he/she has received a diagnosis of schizophrenia, schizophreniform disorder or schizoaffective disorder
-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- admission to a psychiatric unit involuntarily in the context of an ‘inbewaringstelling’ (IBS)
- a history of Parkinson’s disease
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2015
- planned closingdate1-jul-2021
- Target number of participants3700
- InterventionsNone
- Primary outcomeFirst, 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 outcomeSecond, 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
- TimepointsNone
- Trial web sitewww.clozinstudy.com
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Cynthia Pfeifer
- CONTACT for SCIENTIFIC QUERIES Cynthia Pfeifer
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Research funds prof. R.S. Kahn
- PublicationsNone yet
- Brief summaryClozapine (CLZ) is generally prescribed if at least two trials of antipsychotic agents have not led to satisfactory clinical improvement, thereby implying that patients on CLZ generally suffer from more severe and/or persistent symptoms than patients suffering from schizophrenia spectrum disorders (SCZ) on other antipsychotic agents. Unraveling the (functional) genetic variation underlying this severe SCZ phenotype therefore has the potential to deepen our understanding of the biological underpinnings of SCZ beyond the boundaries of DSM-based consensus criteria. Such knowledge in turn has the potential to shape future pharmacotherapeutic research. We here hypothesize that targeting this phenotype in genome-wide association studies and next-generation sequencing studies will signal genetic risk loci implicated in this severe SCZ phenotype. In the future, this may lead to early detection of severe SCZ, which in turn will enable tailoring of pharmacotherapeutic strategies to such SCZ subtypes.

In addition, we use the data with our other protocol (NTR 5257) to create a prediction model for clozapine response and side effects.
- Main changes (audit trail)15-jul-2017 -MT:
Inclusion criteria:
-he/she has received a diagnosis of schizophrenia, schizophreniform disorder or schizoaffective disorder
Replaced by:
-he/she has received a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis not otherwise specified.

Secondary outcome addition:
In addition, we use the data with our other protocol (NTR 5257) to create a prediction model for clozapine response and side effects.
- RECORD11-jun-2015 - 15-jul-2017


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