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A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project

BACKGROUND: The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. METHODS: Sixteen partici...

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Autores principales: Bioque, Miquel, Llerena, Adrián, Cabrera, Bibiana, Mezquida, Gisela, Lobo, Antonio, González-Pinto, Ana, Díaz-Caneja, Covadonga M., Corripio, Iluminada, Aguilar, Eduardo J., Bulbena, Antoni, Castro-Fornieles, Josefina, Vieta, Eduard, Lafuente, Amàlia, Mas, Sergi, Parellada, Mara, Saiz-Ruiz, Jerónimo, Cuesta, Manuel J., Bernardo, Miguel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4851267/
https://www.ncbi.nlm.nih.gov/pubmed/26506856
http://dx.doi.org/10.1093/ijnp/pyv121
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author Bioque, Miquel
Llerena, Adrián
Cabrera, Bibiana
Mezquida, Gisela
Lobo, Antonio
González-Pinto, Ana
Díaz-Caneja, Covadonga M.
Corripio, Iluminada
Aguilar, Eduardo J.
Bulbena, Antoni
Castro-Fornieles, Josefina
Vieta, Eduard
Lafuente, Amàlia
Mas, Sergi
Parellada, Mara
Saiz-Ruiz, Jerónimo
Cuesta, Manuel J.
Bernardo, Miguel
author_facet Bioque, Miquel
Llerena, Adrián
Cabrera, Bibiana
Mezquida, Gisela
Lobo, Antonio
González-Pinto, Ana
Díaz-Caneja, Covadonga M.
Corripio, Iluminada
Aguilar, Eduardo J.
Bulbena, Antoni
Castro-Fornieles, Josefina
Vieta, Eduard
Lafuente, Amàlia
Mas, Sergi
Parellada, Mara
Saiz-Ruiz, Jerónimo
Cuesta, Manuel J.
Bernardo, Miguel
author_sort Bioque, Miquel
collection PubMed
description BACKGROUND: The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. METHODS: Sixteen participating centers from the PEPs project recruited 335 first episode of psychosis patients, aged 7 to 35 years. This article describes and discusses the psychopharmacological interventions and safety profiles at baseline and during a 60-day pharmacovigilance period. RESULTS: The majority of first episode of psychosis patients received a second-generation antipsychotic (96.3%), orally (95%), and in adjusted doses according to the product specifications (87.2%). A total of 24% were receiving an antipsychotic polytherapy pattern at baseline, frequently associated with lower or higher doses of antipsychotics than the recommended ones. Eight patients were taking clozapine, all in monotherapy. Males received higher doses of antipsychotic (P=.043). A total of 5.2% of the patients were being treated with long-acting injectable antipsychotics; 12.2% of the patients received anticholinergic drugs, 12.2% antidepressants, and 13.7% mood stabilizers, while almost 40% received benzodiazepines; and 35.52% reported at least one adverse drug reaction during the pharmacovigilance period, more frequently associated with higher antipsychotic doses and antipsychotic polytherapy (85.2% vs 45.5%, P<.001). CONCLUSIONS: These data indicate that the overall pharmacologic prescription for treating a first episode of psychosis in Spain follows the clinical practice guideline recommendations, and, together with security issues, support future research of determinate pharmacological strategies for the treatment of early phases of psychosis, such as the role of clozapine, long-acting injectable antipsychotics, antipsychotic combination, and the use of benzodiazepines.
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spelling pubmed-48512672016-05-02 A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project Bioque, Miquel Llerena, Adrián Cabrera, Bibiana Mezquida, Gisela Lobo, Antonio González-Pinto, Ana Díaz-Caneja, Covadonga M. Corripio, Iluminada Aguilar, Eduardo J. Bulbena, Antoni Castro-Fornieles, Josefina Vieta, Eduard Lafuente, Amàlia Mas, Sergi Parellada, Mara Saiz-Ruiz, Jerónimo Cuesta, Manuel J. Bernardo, Miguel Int J Neuropsychopharmacol Research Article BACKGROUND: The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. METHODS: Sixteen participating centers from the PEPs project recruited 335 first episode of psychosis patients, aged 7 to 35 years. This article describes and discusses the psychopharmacological interventions and safety profiles at baseline and during a 60-day pharmacovigilance period. RESULTS: The majority of first episode of psychosis patients received a second-generation antipsychotic (96.3%), orally (95%), and in adjusted doses according to the product specifications (87.2%). A total of 24% were receiving an antipsychotic polytherapy pattern at baseline, frequently associated with lower or higher doses of antipsychotics than the recommended ones. Eight patients were taking clozapine, all in monotherapy. Males received higher doses of antipsychotic (P=.043). A total of 5.2% of the patients were being treated with long-acting injectable antipsychotics; 12.2% of the patients received anticholinergic drugs, 12.2% antidepressants, and 13.7% mood stabilizers, while almost 40% received benzodiazepines; and 35.52% reported at least one adverse drug reaction during the pharmacovigilance period, more frequently associated with higher antipsychotic doses and antipsychotic polytherapy (85.2% vs 45.5%, P<.001). CONCLUSIONS: These data indicate that the overall pharmacologic prescription for treating a first episode of psychosis in Spain follows the clinical practice guideline recommendations, and, together with security issues, support future research of determinate pharmacological strategies for the treatment of early phases of psychosis, such as the role of clozapine, long-acting injectable antipsychotics, antipsychotic combination, and the use of benzodiazepines. Oxford University Press 2015-10-27 /pmc/articles/PMC4851267/ /pubmed/26506856 http://dx.doi.org/10.1093/ijnp/pyv121 Text en © The Author 2015. Published by Oxford University Press on behalf of CINP. http://creativecommons.org/licenses/by/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Bioque, Miquel
Llerena, Adrián
Cabrera, Bibiana
Mezquida, Gisela
Lobo, Antonio
González-Pinto, Ana
Díaz-Caneja, Covadonga M.
Corripio, Iluminada
Aguilar, Eduardo J.
Bulbena, Antoni
Castro-Fornieles, Josefina
Vieta, Eduard
Lafuente, Amàlia
Mas, Sergi
Parellada, Mara
Saiz-Ruiz, Jerónimo
Cuesta, Manuel J.
Bernardo, Miguel
A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project
title A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project
title_full A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project
title_fullStr A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project
title_full_unstemmed A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project
title_short A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project
title_sort pharmacovigilance study in first episode of psychosis: psychopharmacological interventions and safety profiles in the peps project
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4851267/
https://www.ncbi.nlm.nih.gov/pubmed/26506856
http://dx.doi.org/10.1093/ijnp/pyv121
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