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Inicio Revista de Psiquiatría y Salud Mental (English Edition) Comparison of aripiprazole and risperidone effectiveness in first episode non-af...
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Vol. 14. Issue 3.
Pages 157-163 (July - September 2021)
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Vol. 14. Issue 3.
Pages 157-163 (July - September 2021)
Clinical trials and protocols
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)
Mayoral-van Son J.a,1,
Corresponding author
, Marcos Gómez-Revueltab,1,
Corresponding author

Corresponding authors.
, Rosa Ayesa-Arriolab, Javier Vázquez-Bourgónb, Víctor Ortiz-García de la Fozb, Miguel Ruiz-Veguillaa, Nathalia Garridoa, Diana Tordesillas-Gutiérrezb, Esther Setién-Suerob, Benedicto Crespo-Facorroa
a Hospital Universitario Virgen del Rocío, Departamento de Psiquiatría, Universidad de Sevilla, IBiS, CIBERSAM, Sevilla, Spain
b Hospital Universitario Marques de Valdecilla, Departamento de Psiquiatría, Universidad de Cantabria, IDIVAL, CIBERSAM, Santander, Spain
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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.


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.


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).


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.

First-episode psychosis


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