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. 2024 May 14:15:1400621.
doi: 10.3389/fpsyt.2024.1400621. eCollection 2024.

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

María Alemany-Navarro  1   2   3 , Bianca Sánchez-Barbero  1   3 , Pablo Reguera-Pozuelo  1   2 , Laura Altea-Manzano  1   3 , Ana Gómez-Garrido  1   3 , Idalino Rocha-González  1   3 , Nathalia Garrido-Torres  1   3   4 , Miguel Ruiz-Veguilla  1   3   4   5 , Susana García-Cerro  1   2   3 , Clara M Rosso-Fernández  6 , José María Villagrán-Moreno  3   7   8   9 , Fernando Sarramea  10 , Jorge Cervilla-Ballesteros  11   12 , Rafael Martínez-Leal  3   13   14 , Fermín Mayoral-Cleries  15 ; CLOZ-AID Group; Benedicto Crespo-Facorro  1   3   4   5
Collaborators, Affiliations

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

María Alemany-Navarro et al. Front Psychiatry. .

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.

Keywords: antipsychotics; clozapine; effectiveness; intellectual disability; resistant psychosis.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Overview of study flow and data. TAU, treatment as usual; CLZ, clozapine.
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