AUTHOR=Alemany-Navarro María , Sánchez-Barbero Bianca , Reguera-Pozuelo Pablo , Altea-Manzano Laura , Gómez-Garrido Ana , Rocha-González Idalino , Garrido-Torres Nathalia , Ruiz-Veguilla Miguel , García-Cerro Susana , Rosso-Fernández Clara M. , Villagrán-Moreno José María , Sarramea Fernando , Cervilla-Ballesteros Jorge , Martínez-Leal Rafael , Mayoral-Cleries Fermín , CLOZ-AID Group , Crespo-Facorro Benedicto , Guillena Samuel Romero , Díaz Álvaro López , Lemos María Dolores Romero , Rivas María Conde , García Ana Rubio , Rivero Manuel Canal , Barragán Rubén Catalán , Pans Irene , Gutierrez María Luisa , Ramos-García Eduardo García , Vilches Ana , Plasencia Beatriz Oda , Terrón Ramón , Valdera Cristina , Rey Manuela , Mármol Demetrio , Esteban Cristina , Castaño Matilde , Alcón Juan Pedro , Vucinovich Nicolás , Capitán Luis R. , García Cándido , Blanco Matilde , Palma Álvaro J. , Caballero Susana Herrera , Laborde Asunta Torres , Olavarrieta Rocío Torrecilla , Macías Melquíades Leon , Montañes Blanca García , Ojeda Juan Luis Prados , Partera José Ángel Alcalá , Urbano Rafael Manuel Gordillo , Expósito Laura Carrión , Moreno Cristina Gómez , Domenech Pablo Glez , Negro José Eduardo Muñoz , Prieto Ángeles Torres , Mas Annabel Folch , Mesa Juan José Mora , Valentín Rosa Mz Galindo San , Salazar Carlos Peña , Panchón Ana Isabel Domínguez , Iturria Cristina Irirte , Hermoso Paula Muñoz , Sanz David Gil , Muñoz Manuel Calvo , Simon Georgia Denisa , Cano Elena Rodríguez , Clotet Edith Pomarol TITLE=Efficacy of clozapine versus standard treatment in adult individuals with intellectual disability and treatment-resistant psychosis (CLOZAID): study protocol of a multicenter randomized clinical trial JOURNAL=Frontiers in Psychiatry VOLUME=15 YEAR=2024 URL=https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1400621 DOI=10.3389/fpsyt.2024.1400621 ISSN=1664-0640 ABSTRACT=Background

Intellectual disability (ID) affects approximately 1% of the worldwide population and individuals with ID have a higher comorbidity with mental illness, and specifically psychotic disorders. Unfortunately, among individuals with ID, limited research has been conducted since ID individuals are usually excluded from mental illness epidemiological studies and clinical trials. Here we perform a clinical trial to investigate the effectiveness of clozapine in the treatment of resistant psychosis in individuals with ID. The article highlights the complexity of diagnosing and treating psychopathological alterations associated with ID and advocates for more rigorous research in this field.

Methods

A Phase IIB, open-label, randomized, multicenter clinical trial (NCT04529226) is currently ongoing to assess the efficacy of oral clozapine in individuals diagnosed with ID and suffering from treatment-resistant psychosis. We aim to recruit one-hundred and fourteen individuals (N=114) with ID and resistant psychosis, who will be randomized to TAU (treatment as usual) and treatment-with-clozapine conditions. As secondary outcomes, changes in other clinical scales (PANSS and SANS) and the improvement in functionality, assessed through changes in the Euro-QoL-5D-5L were assessed. The main outcome variables will be analyzed using generalized linear mixed models (GLMM), assessing the effects of status variable (TAU vs. Clozapine), time, and the interaction between them.

Discussion

The treatment of resistant psychosis among ID individuals must be directed by empirically supported research. CLOZAID clinical trial may provide relevant information about clinical guidelines to optimally treat adults with ID and treatment-resistant psychosis and the benefits and risks of an early use of clozapine in this underrepresented population in clinical trials.

Trial registration

Clinicaltrials.gov: NCT04529226. EudraCT: 2020-000091-37.