We think methylation patterns and gene expression profiles predict treatment outcome (respons + ADRs) after initiating CLZ.
ID
Bron
Verkorte titel
Aandoening
Schizophrenia,schizophreniform and schizoaffective disorder Clozapine, psychotic disorders
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Reponse and the development of ADRs after clozapine intake. We think this is influenced by methylation patterns and gene expression
Achtergrond van het onderzoek
Clozapine (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.
Doel van het onderzoek
We think methylation patterns and gene expression profiles predict treatment outcome (respons + ADRs) after initiating CLZ.
Onderzoeksopzet
Patients have 3 visits: one before clozapine initiation, 4-12 weeks and 28 weeks after steady state.
Onderzoeksproduct en/of interventie
None
Publiek
Marte van der Horst
Heidelberglaan 100
Utrecht 3508 GA
The Netherlands
0887551460
mzvanderhorst@gmail.com
Wetenschappelijk
Marte van der Horst
Heidelberglaan 100
Utrecht 3508 GA
The Netherlands
0887551460
mzvanderhorst@gmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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, 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 with regard to a decision to participate in the current study
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- admission to a psychiatric unit involuntarily in the context of an ‘inbewaringstelling’ (IBS)
- a history of Parkinson’s disease
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5125 |
| NTR-old | NTR5257 |
| CCMO | NL52728.041.15 |
| OMON | NL-OMON50475 |