|- candidate number||22860|
|- NTR Number||NTR5439|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-sep-2015|
|- Secondary IDs||AHDOC-167-001 Achmea Health Database Onderzoekscommissie|
|- Public Title||Early clozapine discontinuation: who is at risk?
|- Scientific Title||Early clozapine discontinuation: who is at risk?
Development of a multivariate prediction model for clozapine discontinuation in a patient population with psychotic disorders
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Psychotic disorders, Schizophrenia, Schizoaffective disorder|
|- Inclusion criteria||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. |
|- Exclusion criteria||-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,
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||15-okt-2015|
|- planned closingdate||15-mrt-2015|
|- Target number of participants||0|
|- Interventions||not applicable (predictive modelling study)|
|- Primary outcome||Discontinuation of clozapine use within one year after the start is the main outcome measure. |
|- Secondary outcome||Discontinuation of clozapine use within 6 months after the start is the main outcome measure. |
|- Timepoints||6 months and 12 months after start of clozapine|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Marieke Beex-Oosterhuis|
|- CONTACT for SCIENTIFIC QUERIES|| Marieke Beex-Oosterhuis|
|- Sponsor/Initiator ||Division of Pharmacoepidemiology & Clinical Pharmacology of the Department of Pharmaceutical Sciences|
(Source(s) of Monetary or Material Support)
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||10-sep-2015 - 18-nov-2015|