Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical Trial

Randomized Controlled Trial

Bibliographic Details
Authors: Garrido-Sánchez, Lucía, Gómez-Revuelta, Marcos, Ortiz-García de la Foz, Víctor, Pelayo-Terán, José María, Juncal-Ruiz, María, Ruiz-Veguilla, Miguel, Mayoral-Van Son, Jacqueline, Ayesa-Arriola, Rosa, Vázquez-Bourgon, Javier, Crespo-Facorro, Benedicto
Format: article
Status:Published version
Publication Date:2022
Country:España
Institution:Consejo Superior de Investigaciones Científicas (CSIC)
Repository:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/405263
Online Access:http://hdl.handle.net/10261/405263
https://api.elsevier.com/content/abstract/scopus_id/85158915477
Access Level:Open access
Keyword:Antipsychotics
Drug-naïve
Effectiveness
First-episode-psychosis
Schizophrenia
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spelling Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical TrialGarrido-Sánchez, LucíaGómez-Revuelta, MarcosOrtiz-García de la Foz, VíctorPelayo-Terán, José MaríaJuncal-Ruiz, MaríaRuiz-Veguilla, MiguelMayoral-Van Son, JacquelineAyesa-Arriola, RosaVázquez-Bourgon, JavierCrespo-Facorro, BenedictoAntipsychoticsDrug-naïveEffectivenessFirst-episode-psychosisSchizophreniaRandomized Controlled Trial[Background] Antipsychotic choice for the acute phase of a first episode of psychosis (FEP) is of the utmost importance since it may influence long-term outcome. However, head-to-head comparisons between second-generation antipsychotics remain scarce. The aim of this study was to compare the effectiveness in the short term of aripiprazole and risperidone after FEP outbreak.[Methods] From February 2011 to October 2018, a prospective, randomized, open-label study was undertaken. Two hundred-sixty-six first-episode drug-naïve patients were randomly assigned to aripiprazole (n = 136) or risperidone (n = 130) and followed-up for 12 weeks. The primary effectiveness measure was all-cause treatment discontinuation. In addition, an analysis based on intention-to-treat principle was conducted to assess clinical efficacy.[Results] The overall dropout rate at 12 weeks was small (6.39%). Effectiveness measures were similar between treatment arms as treatment discontinuation rates (χ 2 = 0,409; P = .522), and mean time to all-cause discontinuation (log rank χ 2 = −1.009; P = .316) showed no statistically significant differences. Despite no statistically significant differences between groups regarding clinical efficacy, aripiprazole required higher chlorpromazine equivalent dosage (χ 2 = 2.160; P = .032) and extended mean time (W = 8183.5; P = .008) to reach clinical response. Sex-related adverse events and rigidity were more frequent in the risperidone group, whereas sialorrhea was on the aripiprazole group.[Conclusions] No differences regarding effectiveness were found between aripiprazole and risperidone for the short-phase treatment of FEP. Despite the importance of efficacy during this phase, differences in side effect profiles and patient’s preferences are essential factors that may lead clinical decisions for these patients.[Clinicaltrials.gov] NCT02532491. Effectiveness of Second-Generation Antipsychotics in First Episode Psychosis Patients: 1-year Follow-up (PAFIP3_1Y).The present study was carried out at the Hospital Marqués de Valdecilla, University of Cantabria, Santander, Spain, under the following grant support: Instituto de Salud Carlos III PI020499, PI050427, PI060507; Plan Nacional de Drogas Research Grant 2005-Orden sco/3246/2004; SENY Fundació Research Grant CI 2005–0,308,007; and Fundación Marqués de Valdecilla API07/011. Unrestricted educational and research grants from AstraZeneca, Pfizer, Bristol-Myers Squibb, and Johnson & Johnson provided support for PAFIP activities. No pharmaceutical industry or institutional sponsors participated in the study concept and design, data collection, analysis and interpretation of the results, and drafting the manuscript.Peer reviewedOxford University PressGómez-Revuelta, Marcos [0000-0002-3749-3801]Vázquez-Bourgon, Javier [0000-0002-5478-3376]Crespo-Facorro, Benedicto [0000-0003-0033-7132]Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]202520252022info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionaplication/pdfhttp://hdl.handle.net/10261/405263https://api.elsevier.com/content/abstract/scopus_id/85158915477reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Ingléshttps://doi.org/10.1093/ijnp/pyac047Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/4052632026-05-22T06:33:51Z
dc.title.none.fl_str_mv Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical Trial
title Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical Trial
spellingShingle Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical Trial
Garrido-Sánchez, Lucía
Antipsychotics
Drug-naïve
Effectiveness
First-episode-psychosis
Schizophrenia
title_short Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical Trial
title_full Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical Trial
title_fullStr Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical Trial
title_full_unstemmed Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical Trial
title_sort Aripiprazole vs Risperidone Head-to-Head Effectiveness in First-Episode Non-Affective-Psychosis: A 3-Month Randomized, Flexible-Dose, Open-Label Clinical Trial
dc.creator.none.fl_str_mv Garrido-Sánchez, Lucía
Gómez-Revuelta, Marcos
Ortiz-García de la Foz, Víctor
Pelayo-Terán, José María
Juncal-Ruiz, María
Ruiz-Veguilla, Miguel
Mayoral-Van Son, Jacqueline
Ayesa-Arriola, Rosa
Vázquez-Bourgon, Javier
Crespo-Facorro, Benedicto
author Garrido-Sánchez, Lucía
author_facet Garrido-Sánchez, Lucía
Gómez-Revuelta, Marcos
Ortiz-García de la Foz, Víctor
Pelayo-Terán, José María
Juncal-Ruiz, María
Ruiz-Veguilla, Miguel
Mayoral-Van Son, Jacqueline
Ayesa-Arriola, Rosa
Vázquez-Bourgon, Javier
Crespo-Facorro, Benedicto
author_role author
author2 Gómez-Revuelta, Marcos
Ortiz-García de la Foz, Víctor
Pelayo-Terán, José María
Juncal-Ruiz, María
Ruiz-Veguilla, Miguel
Mayoral-Van Son, Jacqueline
Ayesa-Arriola, Rosa
Vázquez-Bourgon, Javier
Crespo-Facorro, Benedicto
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Gómez-Revuelta, Marcos [0000-0002-3749-3801]
Vázquez-Bourgon, Javier [0000-0002-5478-3376]
Crespo-Facorro, Benedicto [0000-0003-0033-7132]
Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
dc.subject.none.fl_str_mv Antipsychotics
Drug-naïve
Effectiveness
First-episode-psychosis
Schizophrenia
topic Antipsychotics
Drug-naïve
Effectiveness
First-episode-psychosis
Schizophrenia
description Randomized Controlled Trial
publishDate 2022
dc.date.none.fl_str_mv 2022
2025
2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
http://purl.org/coar/resource_type/c_6501
Publisher's version
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10261/405263
https://api.elsevier.com/content/abstract/scopus_id/85158915477
url http://hdl.handle.net/10261/405263
https://api.elsevier.com/content/abstract/scopus_id/85158915477
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv https://doi.org/10.1093/ijnp/pyac047

dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv aplication/pdf
dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC
instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str DIGITAL.CSIC. Repositorio Institucional del CSIC
collection DIGITAL.CSIC. Repositorio Institucional del CSIC
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