Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study).

UNLABELLED: The effects of galantamine (GAL) on quality of life (QoL) and cognitive speed, as well its effects combined with nimodipine (NIM) in Alzheimer disease (AD) with cerebrovascular disease (mixed dementia), have not been explored. METHOD: Double-blind, placebo-controlled, multicenter Brazilian trial, studying the effects of GAL/NIM vs. GAL/placebo (PLA) in mild to moderate mixed dementia. Patients were randomized to receive GAL/NIM or GAL/PLA for 24 weeks. Primary efficacy measures were changes on a computerized neuropsychological battery (CNTB) and QoL Scale in Alzheimer's Disease (QoL-AD) from baseline to week 24. RESULTS: Twenty-one patients received at least one drug dose (9 GAL/NIM and 12 GAL/PLA). Groups were matched for age, sex, education, cognitive and QoL scores at baseline. No significant differences were observed between groups on primary or secondary measures. QoL and cognitive performance showed significant improvement (p<0.05) from baseline when all GAL-treated patients were analyzed. Adverse events were predominantly mild to moderate. CONCLUSION: GAL treatment improved QoL in mixed dementia, in addition to its previously known cognitive benefits. The combination GAL/NIM was not advantageous. However, the small sample size precludes any definitive conclusions. Trial registered at ClinicalTrials.gov: NCT00814658.

Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study) / Efeitos da galantamina e da galantamina combinada à nimodipina sobre a velocidade de processamento cognitivo e qualidade de vida na demência mista: ensaio clínico exploratório, randomizado e controlado com placebo (estudo REMIX)

The effects of galantamine (GAL) on quality of life (QoL) and cognitive speed, as well its effects combined with nimodipine (NIM) in Alzheimer disease (AD) with cerebrovascular disease (mixed dementia), have not been explored. Method : Double-blind, placebo-controlled, multicenter Brazilian trial, studying the effects of GAL/NIM vs. GAL/placebo (PLA) in mild to moderate mixed dementia. Patients were randomized to receive GAL/NIM or GAL/PLA for 24 weeks. Primary efficacy measures were changes on a computerized neuropsychological battery (CNTB) and QoL Scale in Alzheimer's Disease (QoL-AD) from baseline to week 24. Results : Twenty-one patients received at least one drug dose (9 GAL/NIM and 12 GAL/PLA). Groups were matched for age, sex, education, cognitive and QoL scores at baseline. No significant differences were observed between groups on primary or secondary measures. QoL and cognitive performance showed significant improvement (p<0.05) from baseline when all GAL-treated patients were analyzed. Adverse events were predominantly mild to moderate. Conclusion : GAL treatment improved QoL in mixed dementia, in addition to its previously known cognitive benefits. The combination GAL/NIM was not advantageous. However, the small sample size precludes any definitive conclusions. Trial registered at ClinicalTrials.gov: NCT00814658 .

Os efeitos da galantamina (GAL) sobre qualidade de vida (QdV) e velocidade de processamento cognitivo, bem como da combinação com nimodipina (NIM) no tratamento da doença de Alzheimer (DA) com doença cerebrovascular (demência mista) ainda não foram investigados. Método : Estudo multicêntrico brasileiro, duplo-cego, controlado com placebo, avaliando os efeitos de GAL/NIM x GAL/placebo (PLA) na demência mista leve a moderada. Pacientes receberam tratamento com GAL/NIM ou GAL/PLA por 24 semanas. Medidas de eficácia primária foram as variações no desempenho em bateria de testes neuropsicológicos computadorizados e na escala QdV-DA ao final do estudo. Resultados : Vinte um pacientes receberam pelo menos uma dose da droga (9 GAL/NIM e 12 GAL/PLA). Os grupos foram emparelhados por idade, sexo, escolaridade, escores cognitivos e de QdV na linha de base. Não foram observadas diferenças significativas entre os dois grupos nas medidas de eficácia primária e secundária. Na avaliação de todos os pacientes que receberam GAL, houve melhora significativa (p<0,05) em QdV-DA e desempenho cognitivo. Os eventos adversos foram predominantemente leves a moderados. Conclusão : O tratamento com GAL proporcionou melhora da QdV na demência mista, além dos benefícios cognitivos previamente conhecidos. A combinação GAL/NIM não foi vantajosa. O reduzido tamanho amostral impede conclusões definitivas. .

Switching from oral risperidone to flexibly dosed oral paliperidone extended-release: core symptoms, satisfaction, and quality of life in patients with stable but symptomatic schizophrenia: the RISPALI study.

OBJECTIVE: The purpose of this prospective study was to evaluate the effects of switching from oral risperidone to flexibly dosed oral paliperidone extended-release (ER) in Brazilian adults with schizophrenia because of lack of efficacy, intolerability, or nonadherence after a minimum trial of 30 days on adequate (labeled) doses of oral risperidone, according to individual clinical judgment. RESEARCH DESIGN AND METHODS: Subjects with Positive and Negative Syndrome Scale total scores above 78, and/or intolerable adverse effects, with risperidone received open-label paliperidone ER 3 to 12 mg daily for 26 (main phase) to 52 (extension phase) weeks. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01010776. RESULTS: The intent-to-treat (efficacy) populations comprised 213 subjects in the main phase and 159 in the extension phase. Of 213 subjects with baseline and post-baseline efficacy data, 154 (72.3%) switched from risperidone to paliperidone ER because of a lack of efficacy and 59 (27.7%) because of tolerability issues, according to individual clinical judgment. Paliperidone ER significantly (p < 0.0500) improved a broad spectrum of efficacy endpoints from baseline, as early as the first post-baseline visit (Visit 2; 4 weeks) and persisting through 26 to 52 weeks. On most efficacy endpoints, function improved from baseline to the first post-baseline visit (week 4) and remained significantly improved compared to baseline at each visit for paliperidone ER treatment, at weeks 8, 13, 26, 39, 26, and 52; data are reported herein mainly for 26 and 52 weeks compared to baseline. Significant improvements from baseline were observed for the Positive and Negative Syndrome Scale total score and subscale scores (each p < 0.0001 at 26 and 52 weeks vs. baseline); and personal and social functioning (p < 0.0001 at 26 and 52 weeks). Paliperidone ER also significantly improved health-related quality of life (Short-Form 36) from baseline, particularly on the Mental Component Summary (p = 0.0011 at 26 weeks and p = 0.0019 at 52 weeks). Treatment with paliperidone ER also significantly improved (vs. baseline) sleep quality (according to decreases on the Pittsburgh Sleep Quality Index; p < 0.0001 at each visit vs. baseline) and disease severity (Clinical Global Impression-Severity; p < 0.0001 at each visit vs. baseline). Paliperidone ER was well tolerated. Adverse events occurring in at least 10% of subjects in either phase were insomnia (14.9% in the main phase and 8.8% in the extension phase); increased body weight (10.7% and 12.6%, respectively); and anxiety (10.7% and 2.5%). Most of these adverse events were: 1) rated as mild or moderate; 2) did not prompt interventions such as paliperidone ER dose adjustment or interruption; and 3) decreased in frequency from the main to the extension phase. CONCLUSIONS: Oral paliperidone ER is a rational treatment alternative for patients with schizophrenia whose antipsychotic regimens are switched because of unsuccessful treatment with oral risperidone according to individual clinical judgment. Study limitations included the open-label study design, lack of placebo, and use of subjective clinical judgment to determine lack of efficacy, intolerability, or nonadherence with oral risperidone.

Stigma toward schizophrenia: do all psychiatrists behave the same? Latent profile analysis of a national sample of psychiatrists in Brazil.

BACKGROUND: An important issue concerning the worldwide fight against stigma is the evaluation of psychiatrists' beliefs and attitudes toward schizophrenia and mental illness in general. However, there is as yet no consensus on this matter in the literature, and results vary according to the stigma dimension assessed and to the cultural background of the sample. The aim of this investigation was to search for profiles of stigmatizing beliefs related to schizophrenia in a national sample of psychiatrists in Brazil. METHODS: A sample of 1414 psychiatrists were recruited from among those attending the 2009 Brazilian Congress of Psychiatry. A questionnaire was applied in face-to-face interviews. The questionnaire addressed four stigma dimensions, all in reference to individuals with schizophrenia: stereotypes, restrictions, perceived prejudice and social distance. Stigma item scores were included in latent profile analyses; the resulting profiles were entered into multinomial logistic regression models with sociodemographics, in order to identify significant correlates. RESULTS: Three profiles were identified. The "no stigma" subjects (n = 337) characterized individuals with schizophrenia in a positive light, disagreed with restrictions, and displayed a low level of social distance. The "unobtrusive stigma" subjects (n = 471) were significantly younger and displayed the lowest level of social distance, although most of them agreed with involuntary admission and demonstrated a high level of perceived prejudice. The "great stigma" subjects (n = 606) negatively stereotyped individuals with schizophrenia, agreed with restrictions and scored the highest on the perceived prejudice and social distance dimensions. In comparison with the first two profiles, this last profile comprised a significantly larger number of individuals who were in frequent contact with a family member suffering from a psychiatric disorder, as well as comprising more individuals who had no such family member. CONCLUSIONS: Our study not only provides additional data related to an under-researched area but also reveals that psychiatrists are a heterogeneous group regarding stigma toward schizophrenia. The presence of different stigma profiles should be evaluated in further studies; this could enable anti-stigma initiatives to be specifically designed to effectively target the stigmatizing group.

The more information, the more negative stigma towards schizophrenia: Brazilian general population and psychiatrists compared.

Findings on stigmatizing attitudes toward individuals with schizophrenia have been inconsistent in comparisons between mental health professionals and members of the general public. In this regard, it is important to obtain data from understudied sociocultural settings, and to examine how attitudes toward mental illness vary in such settings. Nationwide samples of 1015 general population individuals and 1414 psychiatrists from Brazil were recruited between 2009 and 2010. Respondents from the general population were asked to identify an unlabeled schizophrenia case vignette. Psychiatrists were instructed to consider "someone with stabilized schizophrenia". Stereotypes, perceived prejudice and social distance were assessed. For the general population, stigma determinants replicated findings from the literature. The level of the vignette's identification constituted an important correlate. For psychiatrists, determinants correlated in the opposite direction. When both samples were compared, psychiatrists showed the highest scores in stereotypes and perceived prejudice; for the general population, the better they recognized the vignette, the higher they scored in those dimensions. Psychiatrists reported the lowest social distance scores compared with members of the general population. Knowledge about schizophrenia thus constituted an important determinant of stigma; consequently, factors influencing stigma should be further investigated in the general population and in psychiatrists as well.

Atitudes de profissionais de saúde mental em relação a indivíduos com esquizofrenia: uma comparação transcultural entre Suíça e Brasil / Attitudes of mental health professionals towards persons with schizophrenia: a transcultural comparison between Switzerland and Brazil

CONTEXTO: A estigmatização é uma questão importante no tratamento e no curso da esquizofrenia. A manutenção de atitudes estigmatizantes pode estar relacionada a fatores socioculturais. OBJETIVOS: Comparar atitudes estigmatizantes de profissionais de saúde mental em países culturalmente diversos: Brasil e Suíça. MÉTODOS: Foram analisados dados de duas grandes pesquisas sobre o estigma na Suíça e no Brasil, focando-se no desejo de distância social em relação a indivíduos com esquizofrenia e atitudes de profissionais de saúde mental em relação à aceitação de efeitos colaterais do tratamento psicofarmacológico. RESULTADOS: Profissionais de saúde mental suíços apresentaram níveis significativamente mais elevados de distância social do que suas contrapartes brasileiras. Houve também um efeito fraco de idade, bem como um efeito da interação entre a origem e a idade. Com relação à aceitação de efeitos colaterais, a influência da origem foi bastante fraca. Com exceção do risco de dependência dos psicotrópicos, a aceitação dos profissionais suíços a efeitos colaterais de longa duração foi significativamente maior do que a de seus colegas no Brasil. CONCLUSÕES: A forte associação entre origem e distância social pode estar relacionada à formação sociocultural dos profissionais de saúde mental; em comparação com a Suíça, o Brasil é muito heterogêneo em termos de estrutura étnica e socioeconômica. A aceitação de efeitos colaterais pode também estar relacionada com os medicamentos mais sofisticados (ou seja, drogas antipsicóticas de nova geração) comumente usados na Suíça.

BACKGROUND: Stigmatization is an important issue in the treatment and course of schizophrenia. The maintenance of stigmatizing attitudes may be related to socio-cultural factors. OBJECTIVES: To compare stigmatizing attitudes of mental health professionals in the culturally diverse countries Brazil and Switzerland. METHODS: We analyzed data of two broad stigmatization surveys from Switzerland and Brazil by focusing on the social distance and attitudes of mental health professionals towards the acceptance of side effects of psychopharmacological treatment. RESULTS: Swiss mental health professionals showed significantly higher levels of social distance than their Brazilian counterparts. There was also a weak effect of age as well as an interaction effect between origin and age. With respect to the acceptance of side effects, the effect of origin was rather weak. With the exception of drug dependence, Swiss professionals' acceptance of long-lasting side effects was significantly higher than for their counterparts in Brazil. DISCUSSION: The strong association between origin and social distance may be related to the socio-cultural background of the mental health professionals. In comparison with Switzerland, Brazil is very heterogeneous in terms of ethnicity and socio-economic structure. The distinct acceptance of side effects may additionally be related to the more sophisticated medicaments (i.e. new generation of antipsychotic drugs) commonly used in Switzerland.

O estigma atribuído pelos psiquiatras aos indivíduos com esquizofrenia / Psychiatrists' stigma towards individuals with schizophrenia

CONTEXTO: A literatura acerca da maneira como a população geral estigmatiza indivíduos com distúrbios mentais aumentou consideravelmente nas últimas décadas. Mas a dúvida sobre se os psiquiatras também estigmatizam seus pacientes ainda permanece. OBJETIVO: O presente estudo visou avaliar as atitudes de psiquiatras brasileiros em relação aos indivíduos com esquizofrenia. MÉTODOS: Dos cerca de 6.000 participantes do Congresso Brasileiro de Psiquiatria em 2009, 1.414 psiquiatras concordaram em participar do estudo. Entrevistas face a face foram realizadas utilizando um questionário que avaliava o estigma em três dimensões: estereótipos, distância social e preconceito, todas relacionadas a alguém com esquizofrenia. Opinião sobre medicações psicotrópicas e tolerância aos efeitos colaterais também foram avaliadas. Dados sociodemográficos e profissionais foram coletados. RESULTADOS: Psiquiatras brasileiros tenderam a estereotipar negativamente pessoas com esquizofrenia. Estereótipos negativos correlacionaram-se com uma melhor opinião sobre medicações psicotrópicas e com maior tolerância a efeitos colaterais. Idade maior correlacionou-se com estereótipos positivos e com menor preconceito. CONCLUSÃO: Os psiquiatras estigmatizam indivíduos com esquizofrenia e possivelmente têm certa dificuldade em admitir esse fato. Campanhas antiestigma para profissionais de saúde mental devem ser promovidas.

BACKGROUND: Literature on how the general population stigmatizes individuals with mental disorders has increased considerably over the last decades. But the question remains if psychiatrists also stigmatize their patients. OBJECTIVE: The present study aimed to assess Brazilian psychiatrists' attitude towards individuals with schizophrenia. METHODS: Out of the approximately 6,000 participants of the 2009 National Psychiatry Congress in Brazil, 1,414 psychiatrists agreed to undergo the survey. Face-to-face interviews were conducted using a questionnaire that assessed stigma in three dimensions: stereotypes, social distance and prejudice towards a person with schizophrenia. Their opinion on psychotropic drugs and tolerance of side-effects were also assessed. Socio-demographic and professional data were collected. RESULTS: Brazilian psychiatrists tend to negatively stereotype individuals with schizophrenia. More negative stereotypes correlated with a positive opinion on psychotropic drugs and with a higher tolerance of side-effects. Higher age was correlated with positive stereotyping and with less prejudice. DISCUSSION: Psychiatrists stigmatize individuals with schizophrenia and possibly find it difficulty admit this fact. Anti-stigma campaigns among mental health professionals should be promoted.