1. 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
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María Alemany-Navarro, Bianca Sánchez-Barbero, Pablo Reguera-Pozuelo, Laura Altea-Manzano, Ana Gómez-Garrido, Idalino Rocha-González, Nathalia Garrido-Torres, Miguel Ruiz-Veguilla, Susana García-Cerro, Clara M. Rosso-Fernández, José María Villagrán-Moreno, Fernando Sarramea, Jorge Cervilla-Ballesteros, Rafael Martínez-Leal, Fermín Mayoral-Cleries, CLOZ-AID Group, Benedicto Crespo-Facorro, Samuel Romero Guillena, Álvaro López Díaz, María Dolores Romero Lemos, María Conde Rivas, Ana Rubio García, Manuel Canal Rivero, Rubén Catalán Barragán, Irene Pans, María Luisa Gutierrez, Eduardo García Ramos-García, Ana Vilches, Beatriz Oda Plasencia, Ramón Terrón, Cristina Valdera, Manuela Rey, Demetrio Mármol, Cristina Esteban, Matilde Castaño, Juan Pedro Alcón, Nicolás Vucinovich, Luis R. Capitán, Cándido García, Matilde Blanco, Álvaro J. Palma, Susana Herrera Caballero, Asunta Torres Laborde, Rocío Torrecilla Olavarrieta, Melquíades Leon Macías, Blanca García Montañes, Juan Luis Prados Ojeda, José Ángel Alcalá Partera, Rafael Manuel Gordillo Urbano, Laura Carrión Expósito, Cristina Gómez Moreno, Pablo Glez Domenech, José Eduardo Muñoz Negro, Ángeles Torres Prieto, Annabel Folch Mas, Juan José Mora Mesa, Rosa Mz Galindo San Valentín, Carlos Peña Salazar, Ana Isabel Domínguez Panchón, Cristina Irirte Iturria, Paula Muñoz Hermoso, David Gil Sanz, Manuel Calvo Muñoz, Georgia Denisa Simon, Elena Rodríguez Cano, and Edith Pomarol Clotet
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clozapine ,intellectual disability ,resistant psychosis ,effectiveness ,antipsychotics ,Psychiatry ,RC435-571 - Abstract
BackgroundIntellectual 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.MethodsA 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.DiscussionThe 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 registrationClinicaltrials.gov: NCT04529226. EudraCT: 2020-000091-37.
- Published
- 2024
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