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Resumen Introduccion En el contexto actual de aumento de la esperanza de vida y progresivo envejecimiento de la poblacion cabe esperar un incremento muy significativo del numero de personas con deterioro cognitivo y demencia. No cabe duda que Espana se enfrenta a un reto de preocupantes dimensiones sociosanitarias en las proximas decadas. El proyecto « Mapa de la enfermedad de Alzheimer y otras demencias en Espana » pretende analizar el estado actual de las herramientas de planificacion y organizacion, actividades de prevencion y deteccion temprana, proceso asistencial y recursos especificos disponibles en las comunidades autonomas para la atencion y el cuidado de las personas con deterioro cognitivo y demencia, con el objeto de identificar las areas de mejora y emitir recomendaciones. Metodologia El grupo de trabajo estuvo formado por un Comite Asesor nacional de 5 expertos y los correspondientes Comites de Expertos de cada comunidad autonoma constituidos por profesionales del ambito de la Neurologia, Geriatria, Psiquiatria y Atencion Primaria asi como representantes de Asociaciones de Familiares de personas con Alzheimer y otras demencias. Se llevaron a cabo reuniones de cada comite local en las que se reviso la situacion actual de la atencion de acuerdo con el cuestionario guia elaborado por el Comite Asesor. Resultados Los planes especificos disponibles en Espana estan en su mayoria obsoletos o no se han llegado a implantar. En lineas generales no se llevan a cabo actividades de prevencion ni de deteccion temprana. Hay una gran heterogeneidad de rutas asistenciales de acceso al diagnostico, tratamiento y seguimiento de la enfermedad y no todas las pruebas diagnosticas estan disponibles en las diferentes regiones sanitarias. En general, los recursos disponibles se consideran escasos y poco conocidos. Conclusiones El estudio Mapa de la enfermedad de Alzheimer y otras demencias en Espana ha permitido detectar los principales puntos susceptibles de cambio y optimizacion tanto en gestion, organizacion y coordinacion de los recursos como en informacion y formacion de las personas implicadas. Ademas, el estudio ha revelado que en Espana se dan las condiciones necesarias de disponibilidad de profesionales implicados y capacitados y de existencia de potenciales recursos diagnosticos y asistenciales para encarar este margen de mejora mediante la aprobacion y el desarrollo de un Plan Nacional de Alzheimer, respaldado por un compromiso de voluntades politicas profundo y veraz, y que sera el marco idoneo para el desarrollo de estas posibilidades.

Objective:Describe and validate the CHROME (CHemical Restraints avOidance MEthodology) criteria.Design:Observational prospective longitudinal study.Setting:Single nursing home in Las Palmas de Gran Canaria, Spain.Participants:288 residents; mean age: 81.6 (SD 10.6). 77.4% had dementia.Intervention:Multicomponent training and consultancy program to eliminate physical and chemical restraints and promote overall quality care. Clinicians were trained in stringent diagnostic criteria of neuropsychiatric syndromes and adequate psychotropic prescription.Measurements:Psychotropic prescription (primary study target), neuropsychiatric syndromes, physical restraints, falls, and emergency room visits were semi-annually collected from December 2015 to December 2017. Results are presented for all residents and for those who had dementia and participated in the five study waves (completer analysis, n=107).Results:For the study completers, atypical neuroleptic prescription dropped from 42.7% to 18.7%, long half-life benzodiazepines dropped from 25.2% to 6.5%, and hypnotic medications from 47.7% to 12.1% (ppConclusions:Implementing the CHROME criteria reduced the prescription of the most dangerous medications in institutionalized people with dementia. Two independent audits found no physical or chemical restraint and confirmed prescription quality of psychotropic drugs. Adequate diagnosis and independent audits appear to be the keys to help and motivate professionals to optimize and reduce the use of psychotropic medication. The CHROME criteria unify, in a single compendium, neuropsychiatric diagnostic criteria, prescription guidelines, independent audit methodology, and minimum legal standards. These criteria can be easily adapted to other countries.

Resumen Introduccion La hiperprolactinemia iatrogenica (HPRLi) se ha descrito con mas frecuencia con algunos antipsicoticos, dependiendo de su capacidad de bloqueo de los receptores de dopamina D2. Existe gran heterogeneidad de la practica clinica y posiblemente falta de concienciacion sobre este problema entre los medicos. Dada la elevada frecuencia con la que los pacientes con enfermedad mental grave reciben antipsicoticos de forma prolongada, se precisa vigilar posibles riesgos en su salud fisica. La HPRLi y sus sintomas pueden pasar desapercibidos si no se investigan rutinariamente. Metodologia Se realiza una revision profunda de la literatura para elaborar un consenso multidisciplinario con psiquiatras junto a otros especialistas (de Endocrinologia, Medicina Interna y Oncologia) con el fin de consensuar los riesgos clinicos y los metodos de deteccion mas adecuados de la HPRLi de acuerdo con los distintos niveles de evidencia cientifica ( I - IV) . Resultados Los sintomas a corto plazo incluyen amenorrea, galactorrea y disfuncion sexual (descenso del deseo y disfuncion erectil por hipogonadismo secundario). A medio-largo plazo y relacionado con la disminucion de estrogenos, se pueden inducir baja masa osea (osteopenia y osteoporosis), hipogonadismo, menopausia precoz, incremento del riesgo de algunos tipos de cancer (mama y endometrio), aumento del riesgo cardiovascular, alteraciones en la inmunidad, dislipidemia y disfuncion cognitiva, entre otros. La peticion de niveles de PRL deberia realizarse al inicio del tratamiento en todos los pacientes que reciben antipsicoticos, aunque no se observen sintomas precoces (amenorrea, galactorrea) por el riesgo de subestimar otros sintomas que pueden aparecen a medio plazo. Se aconseja determinar tambien niveles de FSL, LH, testosterona y vitamina D. Se recomienda explorar rutinariamente la funcion sexual, ya que puede ser un sintoma mal tolerado que podria conducir al abandono del tratamiento. Se propone un especial cuidado en ninos y adolescentes, asi como en pacientes con PRL > 50 ng/ml (intensidad moderada), revisando periodicamente si existe hipogonadismo o disfuncion sexual. En los pacientes con PRL > 150 ng/ml debe descartarse siempre un prolactinoma radiologicamente y se debe prestar especial atencion a posibles antecedentes de cancer de mama o endometrio. Se aconseja realizar densitometrias en varones >50 anos y en mujeres con amenorrea > 6 meses o menopausia precoz para detectar osteoporosis y evitar riesgo de fracturas por fragilidad.

Background and purpose: Traditional Chinese medicine (TCM) MLC601 has shown promising results on functional recovery of patients after stroke. This study aimed to evaluate the pooled effect of its efficacy. Methods: Systematic review and meta-analysis of randomized controlled trials (RCTs) assessing efficacy of MLC601 vs other TCM compounds or placebo. The pooled effect was the relative risk (RR) combined by random effects model. A prediction effect interval was estimated for new studies and a cumulative meta-analysis was performed. Results: Four studies comprising five RCTs were included. The pooled RR was 1.64 (95% CI = 1.05–2.57; p-value = 0.031) favouring MLC601, but heterogeneity was large (I2 = 80%; Q-test p-value = 0.0005). Therefore, the prediction interval was wide and consistent with a null effect (RR range = 0.36–7.45). The cumulative meta-analysis showed a decreasing pattern of effect size through time, with higher effects for trials comparing MLC601 vs other TCM and a systematic decrease of the pooled effect when including later trials comparing MLC601 vs placebo. Conclusions: Evidence on the efficacy of MLC601 has decreased over time and when the comparison arm is placebo instead of other TCM compound. Current evidence suggests MLC601 does not outperform placebo on functional recovery after stroke.

Previous research on theory of mind suggests that people with schizophrenia have difficulties with complex mentalization tasks that involve the integration of cognition and affective mental states. One of the tools most commonly used to assess theory of mind is the Faux-Pas Test. However, it presents two main methodological problems: 1) the lack of a standard scoring system; 2) the different versions are not comparable due to a lack of information on the stories used. These methodological problems make it difficult to draw conclusions about performance on this test by people with schizophrenia. The aim of this study was to develop a reduced version of the Faux-Pas test with adequate psychometric properties. The test was administered to control and clinical groups. Interrater and test-retest reliability were analyzed for each story in order to select the set of 10 stories included in the final reduced version. The shortened version showed good psychometric properties for controls and patients: test-retest reliability of 0.97 and 0.78, inter-rater reliability of 0.95 and 0.87 and Cronbach's alpha of 0.82 and 0.72.

BackgroundPatient's relatives usually care for patients with schizophrenia, and as informal caregivers they experience negative consequences. The aim of the EDUCA-III trial is to test the efficacy of a psychoeducational intervention program (PIP) versus standard care to reduce the caregiver burden at post-intervention (4 months), and at follow-up (8 months).MethodA two-arm, evaluator blind, multicentre, randomized controlled trial. The PIP group had 12 weekly group sessions. The control intervention group had the usual support and standard care. Primary outcomes were change scores since baseline on the Zarit Burden Interview (ZBI) and the Involvement Evaluation Questionnaire (IEQ).ResultsOne hundred and nine caregivers were randomized to PIP and 114 to control condition from 23 research sites. The decrease of ZBI scores was significantly higher on the PIP arm at 4 months (mean difference [MD] = −4.33; 95% CI −7.96, −0.71), and at 8 months (MD = −4.46; 95% CI −7.79, −1.13). There were no significant decreases in the IEQ scores (MD at 4 months = −2.80; 95% CI −6.27, 0.67; MD at 8 months = −2.85; 95% CI −6.51, 0.81).ConclusionsThe PIP condition seems to reduce caregiver burden.Trial registrationISRCTN32545295.

Resumen Introduccion Aunque los recursos sanitarios empleados en la atencion de las demencias en Espana no incluyen sistematicamente a los servicios de salud mental, muchos de los pacientes atendidos en ellos sufren demencia. La perspectiva de los psiquiatras al respecto, no evaluada a nivel nacional hasta la fecha, es de interes para conocer su implicacion real e identificar estrategias para aumentarla. Material y metodos Se realizo una encuesta a una muestra de 2.000 psiquiatras con actividad en diferentes ambitos asistenciales. Se recogieron datos sociodemograficos de los encuestados y sobre aspectos clinicos y opiniones relativos al abordaje de las demencias. Se calcularon las frecuencias de cada opcion de respuesta y medidas de asociacion para las frecuencias cruzadas entre pares de preguntas de interes, junto con sus intervalos de confianza del 95%. Resultados Salvo en unidades de psicogeriatria y centros de larga estancia, la participacion de los psiquiatras en la atencion de las demencias es limitada. No obstante, se observaron diferencias importantes entre comunidades autonomas. Casi todos los encuestados (81%) se mostraron dispuestos a ampliar sus conocimientos en el area de las demencias. Precisamente la falta de formacion, junto con otros factores de tipo organizativo como el dificil acceso a pruebas complementarias (por ejemplo, tecnicas de neuroimagen) o la prescripcion de farmacos antidemencia fueron dificultades comunmente citadas para el abordaje de los pacientes con demencia. Conclusiones El incremento de la implicacion de los psiquiatras y su coordinacion con otros especialistas para proporcionar cuidados integrados son aspectos mejorables de la atencion sanitaria de las demencias en Espana.

In the current context of increased life expectancy and progressive aging of the population a very significant increase in the number of people with cognitive impairment and dementia is expected. Consequently, Spain will face an enormous social and health problem in the next decades. The Mapa de la enfermedad de Alzheimer y otras demencias en España project aims to analyse plans, prevention and early diagnosis activities, process of care and resources available across the 17 Spanish regions for the management of cognitive impairment and dementia in order to identify improvement areas, as well as to provide a list of recommendations.The working group consisted of an Advisory Committee of 5 national experts and a Committee of Experts from each region made up of professionals in the field of Neurology, Geriatrics, Psychiatry, and Primary Care, as well as representatives of Family Associations of People with Alzheimer's and other dementias. The Expert Committee of each region held meetings in which the current situation of care was reviewed.Plans available in Spain for dementia management are mostly obsolete or have not been implemented. Prevention and early detection activities are generally not carried out. There is great variability of care process that patients must follow for the diagnosis, treatment, and follow-up of the disease, and not all diagnostic test are available in different regions. In general, resources are considered scarce and unknown.The Mapa de la enfermedad de Alzheimer y otras demencias en España study has been able to detect the main points that require changing n the management, organisation, and coordination of resources, such as information and training of the personnel involved. Furthermore, the study has revealed that, in Spain, the necessary conditions are in place in Spain, such as the availability and capacity of professionals involved, as well as there being the potential diagnostic and health care resources to address this room for improvement through the approval and development of a National Alzheimer's Plan, supported by a deep and truthful political commitment, which will be the ideal framework for the development of these possibilities.

Hyperprolactinemia is an underappreciated/unknown adverse effects of antipsychotics. The consequences of hyperprolactinemia compromise therapeutic adherence and can be serious. We present the consensus recommendations made by a group of experts regarding the management of antipsychotic-induced hyperprolactinemia. The current consensus was developed in 3 phases: 1, review of the scientific literature; 2, subsequent round table discussion to attempt to reach a consensus among the experts; and 3, review by all of the authors of the final conclusions until reaching a complete consensus. We include recommendations on the appropriate time to act after hyperprolactinemia detection and discuss the evidence on available options: decreasing the dose of the antipsychotic drug, switching antipsychotics, adding aripiprazole, adding dopaminergic agonists, and other type of treatment. The consensus also included recommendations for some specific populations such as patients with a first psychotic episode and the pediatric-youth population, bipolar disorder, personality disorders and the elderly population.

Background People with intellectual disabilities (ID) are usually cared for by their own parents, families or informal caregivers. Caring for a person with ID can have a negative impact on caregivers' mental health (burden, depression, anxiety). The main aim of the EDUCA-IV trial was testing the efficacy of a psychoeducational intervention program (PIP) versus standard practice and to see whether the PIP intervention would reduce the caregiver's burden at post-intervention (4 months) and at follow-up (8 months). Method This was a multi-centre randomised controlled trial including 194 caregivers (96 randomised to PIP, 98 to control condition). PIP intervention consists of 12 weekly group sessions. The control group received treatment as usual. Primary outcomes measured included the Zarit Burden Interview (ZBI). Secondary outcomes were caregivers' mental health (GHQ-28), anxiety (STAI) and depression (CES-D). Results The decrease of ZBI scores was not significant at 4 months. There was significant decrease in the GHQ scores at 4 and 8 months. CES-D showed relevant results at follow-up. Intention to treat analyses showed similar results. Conclusions The PIP intervention seems not to be effective reducing burden, but appears to have a positive result on general mental health. The program was well received and valued by caregivers.

Resumen La complejidad del concepto de sobrecarga del cuidador del paciente con demencia ha dado lugar a gran numero de pruebas de evaluacion, empleando diferentes enfoques. Por ello, puede resultar de utilidad para el clinico o el investigador disponer de una revision de las mismas. Objetivo Efectuar una revision actualizada de los instrumentos disponibles, clasificandolos segun el criterio de sobrecarga, estudiando sus caracteristicas y propiedades psicometricas y presentando con mas detalle aquellos mas relevantes para su aplicacion. Metodo La metodologia aplicada ha sido la busqueda en bases de datos −Pubmed, PsycINFO, Embase y Psicodoc (1980-2012). Resultados Se han seleccionado 31 instrumentos de evaluacion, que han sido agrupados en funcion de 3 enfoques: sobrecarga objetiva/subjetiva, sobrecarga desde un enfoque multidimensional y sobrecarga como estres asociado al deterioro del paciente. Conclusiones Este trabajo proporciona una recopilacion de instrumentos, clasificados de forma que facilite la seleccion y uso de los mismos. Se constata la necesidad de establecer consensos sobre el concepto de sobrecarga y los metodos de evaluacion utilizados para desarrollar un marco de conocimiento uniforme y de aplicacion a la practica asistencial.

Gonzalez-Pinto A, Galan J, Martin-Carrasco M, Ballesteros J, Maurino J, Vieta E. Anxiety as a marker of severity in acute mania. Objective: Anxiety has scarcely been studied in acute mania. The aim of this study was to assess anxiety symptoms during manic episodes and their impact on clinical outcomes. Method: Observational, cross-sectional multicentre study. Anxiety was measured using the Hamilton Anxiety Rating Scale (HARS). Bivariate and multiple linear regression analyses were performed using the HARS score as the dependent variable. Results: Two hundred and forty-two patients admitted with a diagnosis of acute manic episode according to DSM-IV TR criteria and a Young Mania Rating Scale >20 were analysed. Mean age was 43 years (SD = 11.9) and 57% were women. Forty-six per cent of patients (n = 104) presented moderate to severe anxiety symptoms (HARS score >14). Anxiety was significantly associated with severity of manic symptoms (P

Introduction Although it is a troublesome side effect, information on antipsychotic-induced sexual dysfunction is limited. Aim To evaluate the frequency of sexual dysfunction and its impact on treatment adherence in patients with a psychotic disorder treated with various antipsychotics under routine clinical conditions. Methods Subjects included were sexually active male and female patients 18 years of age or older with a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or other psychotic disorder. This was a multicenter, cross-sectional, and naturalistic study conducted by 18 investigators. In addition to sexual functioning, we recorded demographic data, psychiatric diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition), and medication history. Main Outcome Measure Pyschotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ-SalSex). Results All the analyses were performed in the 243 evaluable patients. Most patients were males (71%), and the most common diagnosis was schizophrenia (71%). Overall, 46% of the patients exhibited sexual dysfunction according to the assessment with the SalSex (50% of the males and 37% of the females). Only 37% of the patients with sexual dysfuntion spontaneously reported it. Among the patients exhibiting sexual dysfunction, 32% reported to have poor tolerance to the disturbance. With the exception of conventionals depot, which had a very important and greater effect on females' sexual funtioning, the severity and tolerance of sexual dysfunction were worse in males than in females regardless of the antipsychotic studied. In the univariate logistic regression analysis, using olanzapine as a reference category, risperidone (odds ratio [OR] 7.45, 95% confidence interval [CI] 3.73–14.89) and conventionals, depot (OR 4.57, 95% CI 1.72–12.13) and nondepot (OR 4.92, 95% CI 1.43–16.93), showed a significant increased risk of sexual dysfunction. Conclusions Our results show that sexual dysfunction is very common in patients receiving long-term treatment with antipsychotics, and it is associated with a great impact in a substantial proportion of patients. Montejo AL, Majadas S, Rico-Villademoros F, LLorca G, de la Gandara J, Franco M, Martin-Carrasco M, Aguera L, and Prieto N. Frequency of sexual dysfunction in patients with a psychotic disorder receiving antipsychotics.

This European Psychiatric Association (EPA) guidance paper is a result of the Working Group on Mental Health Consequences of Economic Crises of the EPA Council of National Psychiatric Associations. Its purpose is to identify the impact on mental health in Europe of the economic downturn and the measures that may be taken to respond to it. We performed a review of the existing literature that yields 350 articles on which our conclusions and recommendations are based. Evidence-based tables and recommendations were developed through an expert consensus process. Literature dealing with the consequences of economic turmoil on the health and health behaviours of the population is heterogeneous, and the results are not completely unequivocal. However, there is a broad consensus about the deleterious consequences of economic crises on mental health, particularly on psychological well-being, depression, anxiety disorders, insomnia, alcohol abuse, and suicidal behaviour. Unemployment, indebtedness, precarious working conditions, inequalities, lack of social connectedness, and housing instability emerge as main risk factors. Men at working age could be particularly at risk, together with previous low SES or stigmatized populations. Generalized austerity measures and poor developed welfare systems trend to increase the harmful effects of economic crises on mental health. Although many articles suggest limitations of existing research and provide suggestions for future research, there is relatively little discussion of policy approaches to address the negative impact of economic crises on mental health. The few studies that addressed policy questions suggested that the development of social protection programs such as active labour programs, social support systems, protection for housing instability, and better access to mental health care, particularly at primary care level, is strongly needed.

Introduction: Some studies suggest that venlafaxine, due to its pharmacodynamic characteristics, could be an effective drug in depression, resistant to other antidepressive agents. This investigation explores the efficacy and tolerability of venlafaxine in major depression, resistant to a selective serotonin reuptake inhibitor (SSRI). Methods: A multicenter naturalistic study was performed during 6 months and included those patients diagnosed of major depression according to the criteria of DSM-IV who had a minimum score of 18 on the Hamilton Depression Rating Scale (HAM-D) and who had not responded to previous treatment with a SSRI at therapeutic doses for a minimum of 4 weeks. The assessment of efficacy was performed with the HAM-D scale, the Montgomery–Asberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HAM-A) and the Global Clinical Impression (GCI). Tolerability was evaluated by recording the adverse reactions and with the GCI score on overall drug tolerability. Results: A total of 69 patients, of which 59 were evaluable for efficacy (they had fulfilled at least 4 weeks of treatment), were included. About 81% of all of them obtained a reduction of at least 50% in the HAM-D, 74% were considered as “quite improved” or “very improved” in the GCI and 69% met both criteria. The mean dose of venlafaxine used was 170.4 (S.D.=43.8) mg. Of the 21 patients who did not complete the 6 months of treatment, 3 were due to lack of efficacy, 6 due to adverse effects and 12 for other reasons. About 89.2% of side effects were considered as mild or moderate. Conclusion: The results of our study support the efficacy and tolerability of venlafaxine in patients suffering from depression who have not responded to SSRI treatment.

ERAT: A new tool to assess basic emotions recognition and its application in schizophrenia Abstract : Research about emotion recognition in schizophrenia has shown that patients have a defi cit in perception of negative emotions. There are different tests to assess emotion recognition, but they have several methodological limitations. The aim of the present article was to develop a new tool to assess the six basic emotions. A study was done with 450 control subjects and 60 outpatients with schizophrenia. Fifty-six images were selected to form the test, eight for each basic emotion and eight neutral ones. All photographs had an accuracy higher than 89% and a test-retest reliability between 0.80 and 1.32 for controls, and between 0.61 and 1.92 for outpatients. Overall, data obtained show that the Emotion Recognition Assessment Test (ERAT) may be a good tool to assess emotion recognition in schizophrenia. This test is available for free in www.proyectoscores.es/pere.php Resumen : Los estudios sobre reconocimiento de emociones en esquizofrenia han demostrado que los pacientes presentan un defi cit en la percepcion de emociones negativas. Hay varias pruebas disponibles para evaluar el reconocimiento de emociones, pero tienen inconvenientes de tipo metodologico. El objetivo del presente articulo fue desarrollar un nuevo instrumento para la valoracion de las emociones basicas. El estudio se llevo a cabo con 450 sujetos control y 60 pacientes con esquizofrenia. Se seleccionaron 56 imagenes para formar la prueba, 8 por cada emocion basica y 8 neutras. Todas las fotografias obtuvieron una precision de reconocimiento superior al 89% y una fi abilidad test-retest entre 0.80 y 1 para los sujetos control, y entre 0.61 y 1 para los pacientes. En conjunto, estos resultados indican que la Prueba de Evaluacion del Reconocimiento de Emociones (PERE), disponible gratuitamente en www.proyectoscores.es/pere.php, puede ser una buena herramienta para evaluar el reconocimiento de emociones en esquizofrenia.

With the aging of the population, an increasing number of people have dementia, most of whom are receiving home care. Caregivers are exposed to a variety of stressors, which may lead to feeling burdened, or to depression and anxiety. Various programs or structured interventions have been developed to prevent or lessen these negative consequences. The efficacy of these interventions is debated, mainly due to methodological differences between studies. Review studies so far have presented important discrepancies, thus perpetuating a lack of clarity regarding this important geriatric care problem. The effectiveness of interventions designed to prevent or reduce the burden and/or symptoms of anxiety and depression in informal caregivers are reviewed precisely and rigorously.A systematic review of randomized controlled studies assessing the efficacy of structured interventions on the variables of burden, depression and anxiety in informal caregivers of patients with dementia.The literature search yielded 997 references, of which 35 met the screening criteria. Of these studies, 51.4% had results that were statistically favorable to intervention. The methodology used varied widely between studies.Overall, the available evidence favors the implementation of structured intervention programs, although the results are heterogeneous. Psychoeducational interventions yield better results and can be better adapted to the needs of caregivers.

We conducted a multicenter, prospective, evaluator-blinded, 2-arm parallel randomized trial to compare the effectiveness of a group psychoeducational intervention (PIP) with that of standard care in dementia caregivers. The primary outcome was the burden experience evaluated by the Zarit Burden Interview. Secondary outcomes were psychological distress evaluated with the scaled General Health Questionnaire-28 items, and quality of life evaluated with the Short-Form Health Survey 12. Effectiveness endpoint was at 4 months since inception. Statistical analyses used complete case and intention-to-treat analysis (ITT). The trial recruited 238 caregivers from 22 research sites (115 randomized to PIP, 123 randomized to standard care). No differences were found in the Zarit Burden Interview scores (complete case analysis: mean difference=-1.02, 95% confidence interval=-4.41 to 2.37; ITT analysis: MD=-0.55, 95% confidence interval=-3.64 to 2.55), the Short-Form Health Survey 12 domain scores (all P>0.05), and total General Health Questionnaire-28 items scores and some of its subscales (all P>0.05) except the anxiety and insomnia subscale for the ITT analysis (P=0.03). In summary, PIP in modality of group intervention was not better than standard care to reduce caregiver burden and overall psychological distress or to improve quality-of-life domains. EDUCA-II trial registry: ISRCTN14411440.

The complexity of dementia caregiver burden concept has led to a significant number of assessment tests using various approaches. For this reason, a review of these measurementss could be useful for clinical or research purposes.The objective of the study is to perform an updated review on the tools available, classifying them according to the burden criterion by studying their characteristics and psychometric properties, and providing those most relevant for application.The method applied consisted of a database search -Pubmed, PsycINFO, Embase and Psicodoc (1980-2012).A total of 31 assessment tools were selected, grouped on the basis of the burden concept evaluated: objective/subjective burden, burden from a multidimensional approach, and as distress associated with patient impairment.This study provides a suitable tool for using caregiver burden assessment tools accurately. A marked conclusion is the need to establish agreements in the assessment methods, in order to develop standard knowledge and application to healthcare practice.

Background: Few studies have analyzed predictors of length of stay (LOS) in patients admitted due to acute bipolar manic episodes. The purpose of the present study was to estimate LOS and to determine the potential sociodemographic and clinical risk factors associated with a longer hospitalization. Such information could be useful to identify those patients at high risk for long LOS and to allocate them to special treatments, with the aim of optimizing their hospital management. Methods: This was a cross-sectional study recruiting adult patients with a diagnosis of bipolar disorder (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria) who had been hospitalized due to an acute manic episode with a Young Mania Rating Scale total score greater than 20. Bivariate correlational and multiple linear regression analyses were performed to identify independent predictors of LOS. Results: A total of 235 patients from 44 centers were included in the study. The only factors that were significantly associated to LOS in the regression model were the number of previous episodes and the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at admission (P < 0.05). Conclusions: Patients with a high number of previous episodes and those with depressive symptoms during mania are more likely to stay longer in hospital. Patients with severe depressive symptoms may have a more severe or treatment-resistant course of the acute bipolar manic episode. This study was sponsored by AstraZeneca Spain. MM-C has received honoraria for speaking for Eli Lilly, Lundbeck, Pfizer, Janssen-Cilag, Servier, Esteve, and Novartis, and he has received a research grant from Novartis. AG-P has received grant support, acted as consultant, or given presentations for the following pharmaceutical companies: Almirall, AstraZeneca, Bristol-Myers-Squibb, Otsuka, Eli Lilly, Glaxo-Smith-Kline, Janssen-Cilag, Sanofi-Aventis, Lundbeck, Novartis, Organon, Schering-Plough, Spanish Ministry of Science and Innovation, Department of Health of the Basque Government, University of the Basque Country and Pfizer. JLG was an employee of AstraZeneca Spain when the study was designed, the data were collected, and the statistical analysis was carried out. JB does not have any conflicts of interest to declare. JM is an employee of AstraZeneca Spain. EV received honoraria as member of the EMBLEM Advisory Board from Eli Lilly and Co, and has also received grants unrelated to this study, acted as consultant, or served on advisory boards for the following entities: Astra-Zeneca, Bristol- Myers-Squibb, Eli Lilly, Forest Research Institute, Glaxo-Smith-Kline, Janssen- Cilag, Jazz, Merck-Sharpe & Dohme, Novartis, Organon, Otsuka, Pfizer, Sanofi, Servier, Seventh European Framework Programme (ENBREC), Shering-Plough, Spanish Ministry of Science and Innovation, United Biosource Corporation, and Wyeth.

The objective of this study was to evaluate the prevalence and treatment responsiveness of neuropsychiatric symptoms in patients with mild to moderately severe Alzheimer disease recruited in a naturalistic treatment setting in Spain. All the patients, who matched the prescribing recommendations for donepezil and were able to participate in the study, received donepezil (5 to 10 mg/d) for 6 months. The primary outcome measure was the incidence of adverse events. Secondary outcome measures were neuropsychiatric function measured by the Neuropsychiatric Inventory (NPI), the Mini-Mental State Evaluation, and caregiver burden measured by the Zarit scale. Five hundred and twenty-nine patients were included of which 455 completed the study. The mean baseline NPI score was 19.1. Sixty-five patients (12.3%) experienced an adverse event. The most frequent adverse events were diarrhea and agitation (

Objectives Caregivers of patients with Alzheimer's disease (AD) experience physical and psychological stress due to the caring experience. This study evaluated the benefits of a Psychoeducational Intervention Program (PIP) on caregiver burden in southern Europe. Methods A multicentre, prospective, randomised study was conducted. One hundred and fifteen caregivers of patients with clinical diagnosis of AD (DSM-IV-TR criteria, mini-mental score = 10–26) and functional impairment (Lawton and Brody Scale and Katz Index) were recruited. Caregivers were randomised to receive either PIP (IG: intervention group, n = 60) or standard care (CG: control group, n = 55). PIP consisted of eight individual sessions over 4 months for teaching strategies for confronting problems of AD patient care. Caregivers' stress, quality of life and perceived health were measured using validated scales (Zarit, SF-36, GHQ-28, respectively) at baseline and after 4 and 10-months follow-up. Results Mean change in caregiver burden (Zarit baseline–Zarit final scores) was statistically significant (p = 0.0083) showing an improvement in the IG (−8.09 points) and a worsening in the CG (2.08 points). The IG showed significant improvements in all the well-being perception areas measured by the SF-36 and a significantly lower score in the GHQ-28 (p = 0.0004). 97.7% of caregivers and 88.6% of therapists considered PIP ‘useful/very useful’ at 4 months (the end of PIP) whereas at 10 months the estimates were 93.2% and 86.3%, respectively. Conclusions Psychosocial training of caregivers can minimise caregiver distress and help them to develop problem-solving strategies. A PIP improves quality of life and the perceived health of caregivers of patients with AD. Copyright © 2008 John Wiley & Sons, Ltd.

Objectives To develop a one-dimensional version of the 22-item Zarit Caregiver Burden Interview (ZBI) by applying item response theory approaches. Methods The answers to the 22-item ZBI of 241 caregivers participating in a clinical trial were analyzed 1) with a Mokken nonparametric item response theory analysis to ascertain the dimensional structure underlying the scale and obtain a one-dimensional reduced version, 2) with the Samejima's graded response model to assess the item characteristics of the reduced version, and 3) with confirmatory factor analysis to confirm the unidimensionality of the reduced ZBI version and assess the item loadings to the burden latent variable. Results Mokken analysis resulted in a major one-dimensional scale comprising 12 items directly related with burden. All items showed scalability indices over 0.30. The scalability for the overall scale was 0.44 defining a medium scale according to Mokken's criteria. An unconstrained Samejima's graded response model showed appropriate fit, and most items of the reduced 12-item ZBI presented pertinent difficulty and discrimination parameters. The results of the 12-item ZBI confirmatory factor analysis fitted to a one-dimensional latent structure for burden (comparative fit index=0.975; root-mean-square error of approximation=0.067; weighted root mean square residual=0.677). All factor lodgings were above 0.40 with items 9 (strained by the relative) and 22 (overall feeling of burden) presenting the highest loadings. Conclusions The reduced 12-item ZBI fits a one-dimensional latent variable of burden. Further psychometric studies, focusing on its equivalence for different populations, sensitivity to change, and minimal important difference are warranted.

The aim of this study was to evaluate the clinical effectiveness and tolerability of nefazodone for the treatment of depression in elderly patients in clinical routine practice.Seventy-nine patients with a mean age of 72.81 years, who had major depression or dysthymia according to DSM-IV criteria, were enrolled into this open label study. Patients were prescribed nefazodone starting at 50 mg/day, increasing every 4 days until a dosage of 200 mg/day was attained, and subsequently upward to 600 mg/day if no dose-limiting adverse effects appeared. Effectiveness was evaluated at the end of weeks 2, 4, 8 and 12 by completion of the Hamilton Depression Rating Scale (HAM-D), the Geriatric Depression Scale (GDS) and the Clinical Global Impressions scale. The Hamilton Anxiety Rating Scale (HAM-A), the sleep satisfaction item of the Oviedo Sleep Questionnaire (OSQ) and the Short Portable Mental Status Questionnaire (SPMSQ) were used to assess the patients at the end of week 12. Primary efficacy analysis was based on an intention-to-treat, last-observation-carried-forward data set.HAM-D scores decreased progressively from a baseline mean of 22.3 to 14.2 at the study endpoint; although this was a significant reduction, the endpoint score indicates that a significant residual symptomatology remained in the patients. Similarly, the GDS and HAM-A scores had decreased significantly by week 12. Response and remission rates were 47 and 37.5%, respectively. The percentage of patients who were satisfied, much satisfied or very much satisfied with their sleep according to the OSQ increased from 4.2% at baseline up to 62.2% at the study endpoint. A significant reduction in the SPMSQ total score was observed at the study endpoint, although the clinical relevance of this finding is doubtful. Forty-two (53.2%) patients completed the study. The most common reasons for withdrawal from the study were a lack of efficacy and adverse effects. Most adverse reactions were mild to moderate in severity and included dizziness, dry mouth, gastrointestinal distress, sedation, anxiety and malaise.Our results suggest that nefazodone may be a well tolerated and effective alternative for treating elderly patients with depression. Although the HAM-D score at study endpoint indicated significant residual symptomatology, a similar finding has been described in several meta-analyses of antidepressant treatment in the elderly. Further research is needed to evaluate a different nefazodone dose regimen, especially a slower dose titration rate, which could result in a reduced discontinuation rate and thus a better treatment outcome.

Background: The Zarit Burden Interview ( ZBI) was originally developed to assess the level of subjective burden in caregivers of people with dementia. The Involvement Evaluation Questionnaire ( IEQ) is amongst the leading scales to assess caregiving consequences in severe mental illness. We aimed to compare the psychometric properties of the ZBI, a generic tool, and of the IEQ, a more specific tool to assess the consequences of caregiving in schizophrenia and related disorders. Methods: Secondary analyses of a 16- week, randomized controlled trial of a psychoeducational intervention in 223 primary caregivers of patients with schizophrenia or schizoaffective disorder. Psychometric properties ( internal consistency, convergent and discriminative validity, and sensitivity to change) were evaluated for both ZBI and IEQ. Results: Internal consistency was good and similar for both scales ( ZBI: 0.91, 95% CI: 0.89, 0.94; IEQ: 0.86, 95% CI: 0. 83, 0.89). Convergent validity was relevant for similar domains ( e. g. ZBI total score vs IEQ- tension r = 0.69, 95% CI: 0. 61, 0.75) and at least moderate for the rest of domains ( ZBI total score, personal strain and role strain vs IEQ- urging and supervision). Discriminative validity against psychological distress and depressive symptoms was good ( Area Under the Curve [ AUC]: 0.77, 95% CI: 0.71, 0.83; and 0.69, 95% CI: 0.63, 0.78 - for ZBI against GHQ- 28 and CES- D respectively; and AUC: 0.72, 95% CI: 0.65, 0.78; and 0.69, 95% CI: 0.62, 0.77 - for IEQ against GHQ- 28 and CES- D respectively). AUCs against the reference criteria did not differ significantly between the two scales. After the intervention, both scales showed a significant decrease at endpoint ( p- values < 0.001) with similar standardised effect sizes for change (- 0.36, 95% CI: - 0.58, - 0.15 - for ZBI; - 0.39, 95% CI: - 0.60, - 0.18 - for IEQ). Conclusions: Both ZBI and IEQ have shown satisfactory psychometric properties to assess caregiver burden in this sample. We provided further evidence on the performance of the ZBI as a general measure of subjective burden. The study was entirely funded by a public research grant (FIS PI10/01049, Spain).

The Zarit Burden Inventory (ZBI) is a 22-item self-report scale used to assess patient’s caregiver burden on several dimensions. However, as a multidimensional instrument the clinical interpretation of its total score is sometimes unclear. Because of that, our aim in this study was to try to obtain a short-ZBI unidimensional scale based on Item Response Theory (IRT) and showing appropriate psychometric characteristics.