Observational studySchizophrenia bulletin2021
There Is Life After the UK Clozapine Central Non-Rechallenge Database.
Observational study in Schizophrenia bulletin, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- ACKR1/Duffy-null genotype testing for clozapine: A guideline developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI-PGx).British journal of clinical pharmacology · 2026Guideline
- Clozapine Optimization: A Delphi Consensus Guideline From the Treatment Response and Resistance in Psychosis Working Group.Schizophrenia bulletin · 2023Guideline
- Late-Onset Neutropenia in Clozapine Users: Unrelated or Drug-Induced? A Case-Registry Analysis of Incidence, Characteristics, and Rechallenge Attempts.Schizophrenia bulletin · 2026Article
- Genetic identification of undiagnosed benign ethnic neutropenia in patients receiving clozapine treatment.The British journal of psychiatry : the journal of mental science · 2025Article
- Understanding clozapine-related blood dyscrasias. Developments, genetics, ethnicity and disparity: it's a CIN.BJPsych bulletin · 2025Review
- Identifying clinically relevant agranulocytosis in people registered on the UK clozapine Central Non-Rechallenge Database: retrospective cohort study.The British journal of psychiatry : the journal of mental science · 2024Article
- Mediation and longitudinal analysis to interpret the association between clozapine pharmacokinetics, pharmacogenomics, and absolute neutrophil count.Schizophrenia (Heidelberg, Germany) · 2023Article
- The lived experience of clozapine discontinuation in patients and carers following suspected clozapine-induced neutropenia.BMC psychiatry · 2023Article
- What are the barriers and facilitators of clozapine use in early psychosis? A survey of UK early intervention clinicians.Schizophrenia (Heidelberg, Germany) · 2023Article
- Clozapine haematological monitoring for neutropenia: a global perspective.Epidemiology and psychiatric sciences · 2022Review
- Distinctive pattern of neutrophil count change in clozapine-associated, life-threatening agranulocytosis.Schizophrenia (Heidelberg, Germany) · 2022Article
- Patients' Experiences of Clozapine for Treatment-Resistant Schizophrenia: A Systematic Review.Schizophrenia bulletin open · 2022Article
- Clozapine augmentation with cariprazine for negative symptoms: a case series and literature review.Therapeutic advances in psychopharmacology · 2022Article
- Clozapine for treatment resistance in early psychosis: a survey of UK clinicians' training, knowledge and confidence.Therapeutic advances in psychopharmacology · 2022Article
- Benign ethnic neutropenia: an analysis of prevalence, timing and identification accuracy in two large inner-city NHS hospitals.BMC psychiatry · 2021Observational
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 2 countries.
Funding
Abstract
BACKGROUND AND
aimsIn the United Kingdom, patients on clozapine whose hematological parameters fall below certain thresholds are placed on the Central Non-Rechallenge Database (CNRD), meaning that they cannot be prescribed clozapine again except under exceptional circumstances. This practice was discontinued in the United States in 2015 by expanding the hematological monitoring guidelines, allowing more patients to receive clozapine. Our objective was to investigate the implications this policy change would have on clozapine utilization in the United Kingdom.
methodsThis was an observational, retrospective analysis of patients registered on the CNRD in a large mental health trust. The first objective was to compare the number of patients placed on the CNRD under the United Kingdom and the US Food and Drug Administration (FDA) criteria. The second objective was to explore the hematological and clinical outcomes of CNRD patients. The third objective was to investigate the hematological outcomes of patients rechallenged on clozapine after nonrechallengeable status.
resultsOne hundred and fifteen patients were placed on CNRD from 2002 to 2019, of whom 7 (6%) met the equivalent criteria for clozapine discontinuation under the FDA guidelines. Clinical outcomes, as measured by the Clinical Global Impression-Severity scale, were worse 3 months after clozapine cessation than on clozapine (t = -7.4862; P < .001). Sixty-two (54%) patients placed on CNRD were rechallenged. Fifty-nine of those (95%) were successfully rechallenged; 3 patients were placed back on CNRD, only one of which would have had to stop clozapine again under FDA criteria.
conclusionImplementation of the updated FDA's monitoring criteria in the United Kingdom would significantly reduce clozapine discontinuation due to hematological reasons. The evidence suggests an urgent need for revising the UK clozapine monitoring guidelines to improve outcomes in treatment-resistant schizophrenia.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.