Comparison of aripiprazole and risperidone effectiveness in first episode non-affective psychosis: Rationale and design of a prospective, randomized, 3-phase, investigator-initiated study (PAFIP-3)
| Autor: | Nathalia Garrido, Javier Vázquez-Bourgon, Esther Setién-Suero, Benedicto Crespo-Facorro, Victor Ortiz-García de la Foz, Miguel Ruiz-Veguilla, Mayoral-van Son J, Diana Tordesillas-Gutiérrez, Marcos Gómez-Revuelta, Rosa Ayesa-Arriola |
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| Rok vydání: | 2021 |
| Předmět: |
Olanzapine
Pediatrics medicine.medical_specialty medicine.medical_treatment Aripiprazole Effectiveness Benzodiazepines 03 medical and health sciences 0302 clinical medicine medicine Psychoeducation Humans Antipsychotics Prospective Studies Antipsychotic Clozapine First episode Risperidone business.industry General Medicine First-episode psychosis Discontinuation 030227 psychiatry Clinical trial Psychiatry and Mental health Psychotic Disorders Schizophrenia business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Digital.CSIC. Repositorio Institucional del CSIC instname |
| Popis: | [Background] Selecting the most effective treatment represents a critical challenge with the potential of modifying the long-term prognosis of individuals suffering a first break of psychosis. Head-to-head clinical trials comparing effectiveness among antipsychotic drugs in individuals with a first-episode of non-affective psychosis (FEP) are scarce. [Methods] The rationale and design of a 3 phases clinical trial (PAFIP-3, NCT02305823) comparing the effectiveness of aripiprazole and risperidone, and to additionally assess the benefits of an early use of clozapine in primary treatment-resistant patients is reported. The design encompasses of 5 work packages (medication algorithm, cognitive functioning, psychoeducation/vocational functioning, imaging and biological markers) addressing critical issues and needs of first episode psychosis individuals and their cares. The primary outcome measure was treatment effectiveness assessed by all-cause treatment discontinuation rate. [Results] 266 individuals have been included in the randomization study phase I (risperidone vs. aripiprazole). At 3 months, the retention rate was of 94% (249/266), 48(19.3%) patients have gone through phase II (olanzapine treatment), and 7(2.8%) entered the clozapine phase (phase III). [Discussion] The PAFIP 3 clinical trial may provide relevant information about clinical guidelines to optimally treat patients with a first episode of non-affective psychosis and the benefits and risks of an early use of clozapine in treatment resistant patients. [Clinicaltrials.gov] NCT02305823. |
| Databáze: | OpenAIRE |
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