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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)

Abstract: 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.

Otras publicaciones de la misma revista o congreso con autores/as de la Universidad de Cantabria

 Fuente: Revista de psiquiatría y salud mental (Barcelona) 14 (2021): 157-163

Editorial: Ediciones Doyma, S.L.

 Año de publicación: 2021

Nº de páginas: 7

Tipo de publicación: Artículo de Revista

 DOI: 10.1016/j.rpsm.2021.01.004

ISSN: 1888-9891,1989-4600

Url de la publicación: https://www.doi.org/10.1016/j.rpsm.2021.01.004

Autores/as

MAYORAL-VAN SON, J.

GÓMEZ-REVUELTA, MARCOS

MARIA ROSA AYESA ARRIOLA

ORTIZ-GARCÍA DE LA FOZ, VÍCTOR

RUIZ-VEGUILLA, MIGUEL

GARRIDO, NATHALIA

DIANA TORDESILLAS GUTIERREZ

SETIÉN-SUERO, ESTHER

CRESPO-FACORRO, BENEDICTO