Several reasons for clozapine discontinuation are known, but the current evidence identifying patients who are at risk of discontinuation of clozapine is small and not always consistent. Also cultural differences may question if international…
ID
Bron
Aandoening
Psychotic disorders, Schizophrenia, Schizoaffective disorders
Psychotische stoornissen,Schizofrenie, Schizoaffectieve stoornissen
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Discontinuation of clozapine use within one year after the start is the main outcome measure.
Achtergrond van het onderzoek
Clozapine is almost always the drug of last resort, so when clozapine is initiated no alternatives with proven efficacy remain. However the discontinuation rate of clozapine treatment is disturbingly high, ranging between 18 and 57%. Discontinuation can be a result of serious adverse events, aversion of the necessary, frequent blood tests or a lack of effect. Considering the high frequency of clozapine discontinuation and the numerous reasons for drug cessation, knowing which patients are at risk for discontinuing clozapine, has important implications. It could help the physician to select patients, eligible for clozapine treatment, who need extra care to prevent early, unwarranted discontinuation. Therefore we aim to develop a multivariate predictive model for clozapine discontinuation after twelve months of therapy in a large, both in and outpatient with psychotic disorders in the Netherlands.
Doel van het onderzoek
Several reasons for clozapine discontinuation are known, but the current evidence identifying patients who are at risk of discontinuation of clozapine is small and not always consistent. Also cultural differences may question if international results are generalizable to other countries worldwide. The available evidence of prediction of clozapine discontinuation is based on relatively small, mainly inpatient populations with follow-up periods ranging from 19 months until 15 years, conducted in the United States and Israel. Therefore, the need for a multivariate predictive model for early discontinuation of clozapine in a large, both in and outpatient population in the Netherlands, still remains.
We aim to develop a multivariate predictive model for clozapine discontinuation after twelve months of therapy in a patient population with psychotic disorders.
Onderzoeksopzet
6 months and 12 months after start of clozapine
Onderzoeksproduct en/of interventie
not applicable (predictive modelling study)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All patients, aged 18 years or older, of whom demographical, medical and social data are registered in the AHD and the PCR-MN, between 2001 and 2014, who have been prescribed clozapine are eligible for the study.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-the absence of any drug-dispensing records over the past two years before introduction of clozapine.
-the absence of drug-dispensing data of any drug in the 12 weeks after cessation of clozapine, if applicable,
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5330 |
NTR-old | NTR5439 |
Ander register | Achmea Health Database Onderzoekscommissie : AHDOC-167-001 |