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.

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.

Satisfaction with antipsychotics as a medication: the role of therapeutic alliance and patient-perceived participation in decision making in patients with schizophrenia spectrum disorder.

OBJECTIVES: The aim of this study was to identify independent predictors of satisfaction with antipsychotics in patients with schizophrenia spectrum disorders treated in a mental health catchment area. METHODS: Observational analytical study of patients (n = 150) recruited through a convenience sampling method from five mental health units. Satisfaction with the antipsychotic as a medication was evaluated using the Treatment Satisfaction Questionnaire for Medication (TSQM). Therapeutic alliance was assessed by the Working Alliance Inventory Short Form (WAI-S). Patient-perceived participation in decision-making was assessed using COMRADE (Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness). A multiple linear regression analysis was performed to identify variables independently associated with the TSQM 'Global Satisfaction' total score. RESULTS: Two variables - age and higher level of self-perceived participation in treatment decision-making - were directly, significantly, and independently associated (ß coefficient values: 0.209 and 0.432, respectively) with a higher TSQM Global satisfaction score. In addition, the severity of psychotic symptoms was inversely associated with satisfaction (ß coefficient value: -0.205) (R2 = 0.355; R2 adj. = 0.291; F(13) = 5.554; p < 0.01). CONCLUSIONS: These findings suggest that involving the patient in treatment decision-making and optimising the treatment to reduce symptoms, especially in younger patients, could increase satisfaction with antipsychotic treatment.Key PointsPatient involvement in shared decision-making is relevant for treatment satisfaction.Current evidence suggests that improving the doctor-patient relationship optimises antipsychotics outcomes.Self-perceived participation in decision-making predicts satisfaction with antipsychotic medication.Types of antipsychotics do not determine consistent differences in satisfaction.

Validation of a short version of the Coercion Experience Scale (CES-18): Psychometric characteristics in a Spanish sample.

The Coercion Experience Scale (CES) is a questionnaire that evaluates the subjective experience of coercion during psychiatric hospitalization. This study aimed to assess a short version of the Coercion Experience Scale (CES-18) in a Spanish Sample (N = 114). Two authors independently selected the items, choosing those that could also be applied to the experience of coercion after the use of forced medication. Reliability was estimated using internal consistency coefficients. Internal validity was assessed by means of a factorial analysis based on the method of extraction of main components and using orthogonal rotation VARIMAX. Convergent and discriminatory validity was evaluated by correlation between the total score of the CES-18 with the original CES and a Visual Analogue Scale, The Davidson Trauma Scale and the Client Assessment of Treatment Scale. The CES-18 showed adequate internal consistency (Cronbach α = 0.940). Factor analysis resulted in a two-factor solution (Coercion and Humiliation and Fear) explaining 64.2% of the total variance. The correlation between the original CES and CES-18 was adequate (r = 0.968). The scores suggested good divergent and convergent validity. The Spanish language CES-18 demonstrated adequate psychometric proprieties in order to assess perceived coercion during psychiatric hospitalization.

Patient perceived participation in decision making on their antipsychotic treatment: Evidence of validity and reliability of the COMRADE scale in a sample of schizophrenia spectrum disorders.

OBJECTIVE: The aim of this paper is to provide evidence of the validity and reliability of the COMRADE scale (Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness) in patients suffering from schizophrenia spectrum disorders. METHOD: 150 patients recruited at five mental health centers were assessed using a cross-sectional study design. The COMRADE, WAIS-S (therapeutic alliance) and TSQM (satisfaction with medication) scales were used. RESULTS: Exploratory Factor Analysis identified three factors from the COMRADE (F1: "Risk communication"; F2: "Confidence in decision" and F3: "Knowledge of decisional balance") which explain 45.2, 8.5 and 6% of the variance, respectively. Statistically significant correlations were observed between the scores of the COMRADE subscales with the subscales of the WAI-S and the TSQM. The internal consistency observed for each of the factorial scores of the COMRADE were (Cronbach's alpha values) 0.90, 0.89 and 0.74, respectively. CONCLUSION: The COMRADE scale offers appropriate psychometric properties for its use as a measure of perceived patient involvement in the shared decision making process in antipsychotic treatment. PRACTICE IMPLICATIONS: The use of the COMRADE measure in psychiatric clinical practice and in research studies provides an outcome measure of interventions from the shared decision making model.

El coste económico de los procedimientos de contención mecánica de origen psiquiátrico en España / The economic cost of psychiatric mechanical restraint in Spain

La agitación de origen psiquiátrico ocurre principalmente en pacientes con trastornos psicóticos como la esquizofrenia, el trastorno esquizoafectivo y la fase maníaca del trastorno bipolar. Los métodos tradicionales para el control de los pacientes agitados incluyen la contención verbal, la contención farmacológica y la contención mecánica. En este estudio se ha estimado el coste directo sanitario asociado a la aplicación de las técnicas de contención mecánica de origen psiquiátrico en España. La cuantificación se realizó en función del tiempo empleado por profesional o número de visitas. La valoración de los recursos se realizó a partir de costes unitarios y datos epidemiológicos publicados. La aplicación de un procedimiento de contención mecánica a un paciente psiquiátrico supone un coste total por episodio de 513-1.160 Euros (considerando una duración de 4 a 12 h, respectivamente). El coste total anual se ha estimado en 27 millones de euros, considerando una duración por episodio de 4 h (AU)

Agitation is a group of psychiatric symptoms that commonly occur in patients with psychotic disorders, including schizophrenia, schizoaffective disorder and manic phase of bipolar disorder. Traditional methods of controlling agitated patients include verbal de-escalation, mechanical and pharmacological restraints. This study attempts to determine the direct medical costs attributable to psychiatric mechanical restraint in Spain. This resource was evaluated using published unit costs and national epidemiological data. The estimated direct costs of a restraint episode ranged from Euros 513-Euros 1,160 (4 -12 h per episode duration, respectively). Total annual costs of psychiatric mechanical restraint considering a duration of 4 h per episode were estimated at Euros 27 million (AU)

Degradación de las formaciones psicóticas: un intento de objetivación / Degradation of the psychotic structures: an attempt of objectivation

El proceso de recuperación de la psicosis se lleva a cabo a través de una serie de etapas gradativas; de ahí su denominación de proceso de degradación. Este proceso se basa fundamentalmente en dos fenómenos: la debilitación de la certidumbre acerca de la realidad de la formación psicótica y la desactualización de la misma; o sea, la recuperación de un juicio de realidad correcto, sustitutorio del hasta entonces juicio de realidad psicótico. Con el fin de objetivar el proceso de degradación de la psicosis, y en particular los dos fenómenos señalados, hemos diseñado un cuestionario (CEDEP) que evaluá el grado de certeza que un determinado paciente posee sobre la realidad o ficción de sus formaciones psicóticas, tanto actuales como mnésticas. Este trabajo se inserta en la línea de investigación que Castilla del Pino y colaboradores llevan a cabo sobre la psicopatologia de la conducta psicótica