Laura M Steinauer1, Jonathan G Leung1, Betsy Walters Burkey2, Ian R McGrane3,4, Victoria Letts5, Jessica L Goren6, Dawn M Hoeft7, Sandra Mullen8, Megan Maroney9, Kathryn M Schak10, Jennifer L Vande Voort10. 1. 1 Department of Pharmacy, Mayo Clinic , Rochester, Minnesota. 2. 2 Department of Pharmacy, Fairview Hospital/Cleveland Clinic Children's Hospital , Cleveland, Ohio. 3. 3 Department of Pharmacy, Shodair Children's Hospital , Helena, Montana. 4. 4 Department of Pharmacy Practice, The University of Montana , Missoula, Montana. 5. 5 Department of Pharmacy, The Royal Children's Hospital , Melbourne, Australia . 6. 6 Department of Pharmacy, Cambridge Health Alliance , Cambridge, Massachusetts. 7. 7 Department of Pharmacy, The University of Minnesota Medical Center , Minneapolis, Minnesota. 8. 8 Department of Pharmacy, VCU Health to Virginia Commonwealth University Health, Richmond, Virginia. 9. 9 Department of Pharmacy, Monmouth Medical Center , Long Branch, New Jersey. 10. 10 Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota.
Abstract
OBJECTIVES: Clozapine is the drug of choice for treatment-resistant schizophrenia. While pediatric clozapine use is not contraindicated, the literature describing its clinical application is limited. The primary objective of this study was to assess the use of clozapine in a child and adolescent population by characterizing the documented safety and clinical benefits of the medication. METHODS: A multicenter retrospective study at sites in the United States and Australia included children and adolescents admitted to a psychiatric unit who were administered at least one dose of clozapine. Information related to demographics, patient history, past treatments, clozapine, and adverse events was collected. RESULTS: Eighty-two patients from eight sites were included in this study. Patients were predominantly clozapine naive (76.8%), and most had a discharge diagnosis of a primary psychotic disorder (61%) or bipolar disorder (25.6%). Four clozapine discontinuations occurred during hospitalization due to severe neutropenia, ileus, need for diagnostic clarification, and significant psychomotor retardation. The remainder (n = 78) were discharged on a mean clozapine dose of 218.1 ± 142.2 mg. Sedation (26.8%) and sialorrhea (17.1%) were the most common documented adverse events. The mean number of previously trialed antipsychotics before clozapine was 3.5 ± 1.4 (range 1-10). Improvement with clozapine was documented as significant (31.7%), moderate (32.9%), minimal (12.2%), no improvement (2.4%), and not described (20.7%). CONCLUSIONS: In this cohort, 95% of pediatric patients admitted with or started on clozapine during an acute psychiatric hospitalization were discharged on the medication. The high incidence of adverse events should reinforce to clinicians the need for vigilant monitoring. Pediatric guidelines recommend clozapine for refractory schizophrenia but stress the critical need to ensure an accurate diagnosis. Limited data exist for the use of clozapine in pediatric patients with other diagnoses.
OBJECTIVES:Clozapine is the drug of choice for treatment-resistant schizophrenia. While pediatric clozapine use is not contraindicated, the literature describing its clinical application is limited. The primary objective of this study was to assess the use of clozapine in a child and adolescent population by characterizing the documented safety and clinical benefits of the medication. METHODS: A multicenter retrospective study at sites in the United States and Australia included children and adolescents admitted to a psychiatric unit who were administered at least one dose of clozapine. Information related to demographics, patient history, past treatments, clozapine, and adverse events was collected. RESULTS: Eighty-two patients from eight sites were included in this study. Patients were predominantly clozapine naive (76.8%), and most had a discharge diagnosis of a primary psychotic disorder (61%) or bipolar disorder (25.6%). Four clozapine discontinuations occurred during hospitalization due to severe neutropenia, ileus, need for diagnostic clarification, and significant psychomotor retardation. The remainder (n = 78) were discharged on a mean clozapine dose of 218.1 ± 142.2 mg. Sedation (26.8%) and sialorrhea (17.1%) were the most common documented adverse events. The mean number of previously trialed antipsychotics before clozapine was 3.5 ± 1.4 (range 1-10). Improvement with clozapine was documented as significant (31.7%), moderate (32.9%), minimal (12.2%), no improvement (2.4%), and not described (20.7%). CONCLUSIONS: In this cohort, 95% of pediatric patients admitted with or started on clozapine during an acute psychiatric hospitalization were discharged on the medication. The high incidence of adverse events should reinforce to clinicians the need for vigilant monitoring. Pediatric guidelines recommend clozapine for refractory schizophrenia but stress the critical need to ensure an accurate diagnosis. Limited data exist for the use of clozapine in pediatric patients with other diagnoses.
Authors: Giuseppe Cicala; Maria A Barbieri; Vincenza Santoro; Carmela Tata; Pia V Colucci; Francesca Vanadia; Flavia Drago; Carmelita Russo; Paola M Cutroneo; Antonella Gagliano; Edoardo Spina; Eva Germanò Journal: Front Psychiatry Date: 2020-03-24 Impact factor: 4.157