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A better understanding of the response and side effect of clozapine use


- candidate number22363
- NTR NumberNTR5257
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jun-2015
- Secondary IDsABR:NL52728.041.15 
- Public TitleA better understanding of the response and side effect of clozapine use
- Scientific TitlePhenomics & Genomics of Clozapine Pharmacotherapy – New Users
- ACRONYMCLOZIN
- hypothesisWe think methylation patterns and gene expression profiles predict treatment outcome (respons + ADRs) after initiating CLZ.
- Healt Condition(s) or Problem(s) studiedClozapine, Schizoaffective disorder, Schizophrenia, Schizophreniform disorder
- Inclusion criteria-he/she is about to initiate CLZ (i.e. he/she has an indication to start CLZ treatment according to the treating physician and he/she is willing to start on 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 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 participants300
- InterventionsNone
- Primary outcomeReponse and the development of ADRs after clozapine intake. WE think this in influences by methylation patterns and gene expression
- Secondary outcomeWe measure non-genetic factors such as smoking, cannabis use, duration of illness etc., because we think these influence treatment outcome (ADRs+response) as well.
- TimepointsPatients have 2 visits: one before clozapine initiation, 8-28 weeks after steady state.
- Trial web sitewww.clozinstudy.com
- statusplanned
- 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
- Publications
- Brief summaryClozapine (CLZ) is one of the most effective antipsychotic medications, but with life-threatening adverse drug reactions (ADRs), such as agranulocytosis, diabetic ketoacidosis and gastrointestinal hypomotility and insidious adverse reactions such as metabolic syndrome (MetS). For many patients with schizophrenia spectrum disorders (SCZ), CLZ is the last resort because other antipsychotics have not resulted in sufficient clinical improvements. Prescribing CLZ in clinical practice therefore requires balancing ADR risk profile likelihoods with clinical response probabilities. This need highly contrasts with the current state of knowledge as it is unknown who will respond to CLZ and to what degree a specific patient may develop ADRs. Based on preclinical studies, we hypothesize that epigenetic and gene expression mechanisms influence treatment outcome (response + development ADRs) of CLZ. We will therefore investigate methylation patterns and gene expression profiles before and after initiation of CLZ pharmacotherapy. Furthermore, we will try and identify other predictive factors for treatment outcome following CLZ pharmacotherapy initiation.

In addition, we use the data with our other protocol (NTR 5248) 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.

Timepoints:
Patients have 2 visits: one before clozapine initiation, 8-28 weeks after steady state.
Replaced by:
Patients have 3 visits: one before clozapine initiation, the second 4-12 weeks when steady state, the third after 6 months from visit 1.
- RECORD19-jun-2015 - 15-jul-2017


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