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Pharmacovigilance in Action: Utilizing VigiBase Data to Improve Clozapine Safety.
Patient Prefer Adherence
November 2024
Mental Health Research Center, Eastern State Hospital, Lexington, KY, USA.
Purpose: Clozapine is an antipsychotic which was approved in 1989 for treatment-resistant schizophrenia in the United States (US). There were few randomized trials before its approval and potentially lethal clozapine adverse drug reactions (ADRs), such as agranulocytosis and myocarditis were identified by pharmacovigilance. VigiBase, the WHO global database, is a cornerstone of international pharmacovigilance efforts for ADR identification during post-marketing surveillance.
View Article and Find Full Text PDFBackground: Although clozapine is the most effective antipsychotic for people with treatment-resistant schizophrenia (TRS), only 40% of people with TRS respond, and there is limited evidence for augmentation agents. Cannabidiol (CBD) reduces positive symptoms in individuals with schizophrenia, but no trials have specifically examined its efficacy in those with clozapine-resistant schizophrenia.
Aims: To examine the clinical efficacy of CBD augmentation in people with clozapine-resistant schizophrenia.
Clozapine, relapse, and adverse events: a 10-year electronic cohort study in Canada.
Br J Psychiatry
December 2024
Division of Child and Adolescent Psychiatry, University of Saskatchewan, Canada.
Background: Clozapine is the most effective medication for treatment-resistant psychoses, but the balance of benefits and risks is understudied in real-world settings.
Aims: To examine the relative re-hospitalisation rates for mental health relapse and adverse events associated with clozapine and other antipsychotics in adult and child/youth cohorts.
Method: Data were obtained from the Canadian Institute of Health Information for adults ( = 45 616) and children/youth ( = 1476) initially hospitalised for mental health conditions in British Columbia, Manitoba and Saskatchewan from 2008 to 2018.
Correction: Electroconvulsive Therapy Versus Aripiprazole Addition to Clozapine in Patients with Clozapine-Resistant Symptoms (EMECLO): A Protocol of a Single-Blind, Multicenter, Randomized-Controlled Feasibility Trial.
Pharmacopsychiatry
November 2024
Department of Psychiatry, Amsterdam UMC, The Netherlands.
Electroconvulsive Therapy Versus Aripiprazole Addition to Clozapine in Patients with Clozapine-Resistant Symptoms (EMECLO): A Protocol of a Single-Blind, Multicenter, Randomized-Controlled Feasibility Trial.
Pharmacopsychiatry
November 2024
Department of Psychiatry, Amsterdam UMC, The Netherlands.
Background: Currently, guidance on the most effective treatment for patients with clozapine-resistant schizophrenia-spectrum disorders (SSD) is lacking. While augmentation strategies to clozapine with aripiprazole and electroconvulsive therapy (ECT) have been demonstrated to be effective in patients with clozapine-resistant schizophrenia spectrum disorders (CRS), head-to-head comparisons between these addition strategies are unavailable. We therefore aim to examine the feasibility of a larger randomized, single-blind trial comparing the effectiveness, cost-effectiveness, and safety of aripiprazole addition vs.
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