| アブストラクト | BACKGROUND: In the United States, clozapine was first approved for treatment-resistant schizophrenia and then for suicidality in schizophrenia psychoses. Systematic reviews support clozapine's anti-suicidal effect, but the forensic literature stresses its lethality during overdoses. RESEARCH DESIGN AND METHODS: Clozapine reports to the international pharmacovigilance database (VigiBase) were analyzed for suicidal ideation, suicide attempts, intentional overdose, and completed suicides from introduction to 1 January 2024. VigiBase uses the information component (IC) as a disproportionality analysis. RESULTS: The clozapine ICs (range: other antipsychotics) were: 1) suicidal ideation IC = 0.570 with IC(025) = 0.454 to IC(975) = 0.680 (IC = 3.568 for aripiprazole and 1.729 for risperidone), 2) suicide attempt IC = 1.428 with IC(025) = 1.323 to IC(975) = 1.529 (IC = 4.150 for quetiapine and 2.968 for risperidone), 3) intentional overdose: IC = 0.995 with IC(025) = 0.864 to IC(975) = 1.120 (IC = 4.080 for quetiapine and 1.957 for aripiprazole), and 4) completed suicide IC = 1.133 with IC(025) = 1.026 to IC(975) = 1.235 (IC = 4.648 for quetiapine and 2.160 for risperidone). In summary, all clozapine ICs were significantly lower. We found 2391 clozapine-treated patients on the suicidality spectrum (627 cases with suicidal ideation, 752 with suicide attempt, 488 with intentional overdose, and 731 with completed suicide) but many were taking other antipsychotics. The most frequent reporting countries were the United States, the United Kingdom, and Croatia. CONCLUSION: This pharmacovigilance study, with all its inherent limitations, provides independent proof, not overlapping with prior literature, that clozapine may have specific strong anti-suicidal effects that do not appear to be present in other antipsychotics. Further VigiBase studies are needed to compare the lethality of an intentional overdose of clozapine (14.3%) with other antipsychotics. |
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| 組織名 | Department of Internal Medicine, Dermatology, and Psychiatry and Instituto;Universitario de Neurociencia (IUNE), Universidad de La Laguna, La Laguna, Spain.;Department of Psychiatry, Washington University School of Medicine in St Louis,;St Louis, MO, USA.;Instituto de Investigacion, Transferencia e Innovacion, Ciencias de la Saludy;Escuela de Doctorado, Universidad Internacional de La Rioja, Logrono, Spain.;Emooti, Madrid, Spain.;Center of Biomedical Network Research on Mental Health (CIBERSAM), Carlos III;Institute of Health, Madrid, Spain.;Department of Psychiatry, Hospital Fundacion Jimenez Diaz, Madrid, Spain.;Complutense University of Madrid, Madrid, Spain.;Universidad Catolica del Maule, Talca, Chile.;Department of Psychiatry, Centre Hospitalier Universitaire de Nimes, Nimes,;France.;School of Medicine, University of Zagreb, Zagreb, Croatia.;University Hospital Centre Zagreb, Zagreb, Croatia.;Department of Physical Medicine and Pharmacology, School of Medicine, Universidad;de La Laguna, Spain.;Hospital Universitario de Canarias, Tenerife, Spain.;Mental Health Research Center, Eastern State Hospital, Lexington, KY, USA.;Biomedical Research Centre in Mental Health Net (CIBERSAM), Santiago Apostol;Hospital, University of the Basque Country, Vitoria, Spain. |
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