Randomized clinical trial on the efficacy of a new transcranial direct current stimulation (tDCS) device in the treatment of depression: a low-cost option for developing countries? / Ensaio clínico randomizado sobre a eficácia de novo equipamento de estimulação transcraniana por corrente contínua (ETCC) no tratamento da depressão: uma opção de baixo custo para países em desenvolvimento?

ABSTRACT Objective: Verify the clinical efficacy and safety of a low-cost tDCS device, in a clinical trial for major depressive disorder. Methods: 168 persons were recruited; 32 depressed individuals with moderate or severe depressive symptoms (HDRS17 scores higher than 18) were included and randomized for the trial (16 individuals in each group). The intervention consisted of 10 active anodal tDCS sessions at 2 mA for 30 minutes over the left dorsolateral prefrontal cortex; or sham. The main outcome was HDRS17; secondary outcomes included satisfaction (TSQM II) and quality of life (WHOQOL-BREF). Assessments at baseline, endpoint and at 30 days follow-up. Results: The sample was composed by a total of 11 men and 21 women, mean age of 42.75 years (95% CI: 38.10-47.40). Active treatment was superior than sham: There was a significant interaction between group and time regarding HDRS-17 scores (F = 4.089, df = 2, p = 0.029; partial Eta squared = 0. 239). Post hoc analyses exhibited a statistically significant difference between active and sham group symptoms after a 30 days follow-up (difference = -7.75, p = 0.008, Cohen's d = 1.069). There were 3 dropouts, all in the active group, due schedule issues. No severe adverse effects reported. Conclusion: The current active tDCS protocol was related with clinical improvement of depressive symptoms. Intervention was well-tolerated. Non-invasive brain stimulation techniques are still not routinely used, although a viable strategy for treatment-resistant patients, partial responders and people unable to use pharmacological treatment. We aim to increase knowledge and use of tDCS for the Brazilian population.

RESUMO Objetivo: Testar a eficácia clínica e a segurança de equipamento de estimulação elétrica transcraniana por corrente contínua (ETCC) de baixo custo em ensaio clínico para transtorno depressivo maior (TDM). Métodos: Foram recrutadas 168 pessoas e incluídos e randomizados 32 indivíduos com depressão moderada ou grave (escores na HDRS17 >18; 16 indivíduos em cada grupo). A intervenção consistiu de 10 sessões de ETCC ativa a 2 mA no córtex pré-frontal dorsolateral esquerdo por 30 minutos, ou sham. O desfecho principal foi HDRS17; os desfechos secundários foram satisfação (TSQM II) e qualidade de vida (WHOQOL-BREF). Avaliações no início, no final do tratamento e após 30 dias de seguimento. Resultados: A amostra foi composta de 11 homens e 21 mulheres, com idade média de 42,75 anos (IC 95%: 38,10 a 47,40). O tratamento ativo foi superior ao sham: houve interação significativa entre grupo e tempo em relação aos escores de HDRS17 na ANOVA (F = 4,089, df = 2, p = 0,029; partial Eta squared = 0,239). A análise post hoc mostrou diferença significativa na HDRS17 no follow-up após 30 dias (diferença = -7,75, p= 0,008, Cohen's d = 1,069). Houve 3 dropouts, todos no grupo ativo, devido a problemas de agenda. Não houve registro de efeitos adversos graves. Conclusão: O tratamento ativo teve relação com melhora clínica de sintomas depressivos. A intervenção foi bem tolerada. Técnicas de estimulação cerebral não invasivas ainda não são rotina na prática clínica, apesar de estratégias viáveis para pacientes resistentes a tratamento, respondedores parciais e pessoas com intolerância a medicamentos. Esperamos ampliar o conhecimento e o uso de protocolos de ETCC na população brasileira.

Forensic Implications of the New Classification of ICD-11 Paraphilic Disorders in Brazil.

INTRODUCTION: The World Health Organization (WHO) Department of Mental Health and Substance Abuse appointed a Working Group on Sexual Disorders and Sexual Health in order to revise and propose changes to ICD-10 categories. AIM: Analyze ethical and legal implications in Brazil of the proposed ICD-11 diagnostic criteria for paraphilic disorders. METHODS: A forensic working group of Brazilian experts in collaboration with representatives of WHO reviewed the proposed modifications to the classification of Disorders of Sexual Preference in ICD-10 (F65), which is recommended to be replaced by Paraphilic Disorders in ICD-11. Proposals were reviewed through a medicolegal lens, using a legal and policy analysis guide put forth by WHO. The premise of this review was to understand that, although the ICD classification is intended to provide a basis for clinical and statistical health interventions, medical diagnostics may also be entangled in the complex legal, normative, and political environment of various countries. MAIN OUTCOME MEASURE: The most important proposed change to this section is to limit the concept of paraphilic disorders primarily to patterns of sexual arousal involving a focus on others who are unwilling or unable to consent, but this change has not affected the ethical and legal aspects of psychiatric functioning in the Brazil. RESULTS: Because Brazilian criminal law is directed toward criminal behavior and not to specific psychiatric diagnoses, the changes proposed for ICD-11 are not expected to create obstacles to health services or to modify criminal sentencing. CLINICAL IMPLICATIONS: Although ICD-11 has a number of changes in its content, there are no significant clinical implications in the Brazilian context, but a better clarity of conceptual definitions and diagnostic criteria. STRENGTHS & LIMITATIONS: The study is conducted with people from different Brazilian states, which is important for a comprehensive view. On the other hand, considering that it is a very heterogeneous country, there is the limitation that an even wider scope of the study is not possible. CONCLUSION: In the Brazilian context, the new guidelines for paraphilic disorders contribute to clinical utility and are not expected to create difficulties related to the legal, social, and economic consequences of sexual offenses in the country. Abdalla-Filho E, de Jesus Mari J, Diehl A, et al. Forensic Implications of the New Classification of ICD-11 Paraphilic Disorders in Brazil. J Sex Med 2019; 16:1814-1819.

Efficacy of electroconvulsive therapy augmentation for partial response to clozapine: a pilot randomized ECT – sham controlled trial

Abstract Background Thirty percent of schizophrenia patients are treatment-resistant. Objective This is a single-blinded sham-controlled trial to assess the efficacy of electroconvulsive therapy (ECT) as augmentation strategy in patients with clozapine-resistant schizophrenia. Methods Twenty three subjects were randomly assigned to 12 sessions of ECT (N = 13) or placebo (Sham ECT) (N = 10). The primary outcome was improvement on psychotic symptoms as measured by the mean reduction of the PANSS positive subscale. The assessments were performed by blind raters. Results At baseline both groups were similar, except for negative and total symptoms of the PANSS, which were higher in the Sham group. At the endpoint both groups had a significant decrease from basal score. In the ECT group the PANSS total score decreased 8.78%, from 81.23 to 74.75 (p = 0.042), while the positive subscale had a mean reduction of 19% (19.31 to 16.17, p = 0.006). In the Sham group, the mean reduction of PANSS total score was 15.27% (96.80 to 87.43; p = 0.036), and the PANSS positive subscale decreased 27.81% (22.90 to 19.14, p = 0.008). The CGI score in ECT group decreased 23.0% (5.23 to 4.17; p = 0.001) and decreased 24.31% in the Sham ECT group (5.80 to 4.86; p = 0.004). Discussion In this pilot study, we found no difference between the groups.

Public health system and psychiatry in the treatment of 'dangerous' young offenders in Brazil.

We describe the Experimental Health Unit, a special forensic mental health facility in Brazil, created by court order and administered by the São Paulo Department of Health. It was designed for young offenders receiving compulsory inpatient treatment for severe personality disorders. All nine patients admitted to date came from Foundation CASA (a socio-educational centre of assistance for adolescents, the juvenile correctional centres managed by the São Paulo state Department of Justice). The court decision is questionable, relying on a new interpretation of the Child and Adolescent Statute and the law that regulates psychiatric treatment in Brazil. The public health system and psychiatry have been supporting the isolation of some individuals from society, based on the seriousness of their crimes and possession of particular personality characteristics. The decision to commit and send a small group of personality disordered individuals to this unit as inpatients is an unfair decision, since jails and correctional centres hold a high number of psychopathic who have also committed barbaric crimes. The central mental health issue is the role that the public health system should play in the custody of dangerous people; the cost-effectiveness of this model, the accuracy of risk assessment and tractability of people with severe personality disorders are also debatable. From a legal perspective, the operation of this facility raises questions about age of legal majority, the maximum period of incarceration of young offenders and use of whole-life sentences for certain types of crimes and criminals in Brazil.

Clinical characteristics and outcomes on discharge of women admitted to a Medium Secure Unit over a 4-year period.

There are limited data on women in Medium Secure settings. This study aimed to address this by assessing the characteristics of 45 consecutive admissions to the female ward of a Medium Secure Unit in the United Kingdom over a four-year period. Data on demographics, clinical outcomes and from HONOS-Secure/HONOS and HCR-20 assessments were prospectively collected. Psychiatric diagnoses were recorded using ICD-10 criteria. Data on quality of life from WHO-QoL-BREF surveys were analysed. There was a high proportion of ethnic minorities (57.8%), high rates of childhood and adult abuse and low socioeconomic status. 62.2% of the patients had schizophrenia, 57.8% had multiple diagnoses. The median length of stay at discharge was 465.5 days. There were statistically significant reductions in rates of self-harm and HoNOS-Secure/HoNOS and HCR-20 scores following intervention. Scores on WHO-QoL-BREF compared favourably to a large-scale sample with mental health difficulties. Many characteristics of this sample were comparable to samples from similar populations. However the particularly high proportion of ethnic minorities suggested that the profile of our patients differs from nationwide samples. Intervention by our service was associated with reduced self-harm and improvements in well-defined clinical outcomes and quality of life measures using validated scales.

Electroconvulsive therapy in Brazil after the "psychiatric reform": a public health problem--example from a university service.

OBJECTIVES: The Brazilian public health system does not provide electroconvulsive therapy (ECT), which is limited to a few academic services. National mental health policies are against ECT. Our objectives were to analyze critically the public policies toward ECT and present the current situation using statistics from the Institute of Psychiatry of the University of São Paulo (IPq-HCFMUSP) and summary data from the other 13 ECT services identified in the country. METHODS: Data regarding ECT treatment at the IPq-HCFMUSP were collected from January 2009 to June 2010 (demographical, number of sessions, and diagnoses). All the data were analyzed using SPSS 19, Epic Info 2000, and Excel. RESULTS: During this period, 331 patients were treated at IPq-HCFMUSP: 221 (67%) were from São Paulo city, 50 (15.2%) from São Paulo's metropolitan area, 39 (11.8%) from São Paulo's countryside, and 20 (6.1%) from other states; 7352 ECT treatments were delivered-63.0% (4629) devoted entirely via the public health system (although not funded by the federal government); the main diagnoses were a mood disorder in 86.4% and schizophrenia in 7.3% of the cases. CONCLUSIONS: There is an important lack of public assistance for ECT, affecting mainly the poor and severely ill patients. The university services are overcrowded and cannot handle all the referrals. The authors press for changes in the mental health policies.

Evaluation of Helicobacter pylory colonization by serologic test (IgG) and dyspepsia in volunteers from the countryside of Monte Negro, in the Brazilian western Amazon region / Avaliação da colonização por Helicobacter pylori através de teste sorológico (IgG) e de dispepsia em voluntários da população rural de Monte Negro (RO), região da Amazônia ocidental

The present study intended to analyze the seroprevalence of Helicobacter pylori, IgG, and its relation to dyspepsia in a population from the western Amazon region. During the "Projeto Bandeira Científica", a University of São Paulo Medical School program, in Monte Negro's rural areas, state of Rondônia, 266 blood samples were collected from volunteers. The material was tested for IgG antibodies anti-Helicobacter pylori by ELISA method and the participants were also interviewed on dyspepsia, hygiene and social aspects. Participants aged between five and 81 years old (34 years on average), 149 (56 percent) were female and 117 (44 percent) male. We found 210 (78.9 percent) positive, 50 (18.8 percent) negative and six (2.3 percent) undetermined samples. Dyspeptic complaints were found in 226 cases (85.2 percent). There was no statistical association between dyspepsia and positive serology for H. pylori. We concluded that the seroprevalence in all age categories is similar to results found in other studies conducted in developing countries, including those from Brazil. On the other hand, the seroprevalence found in Monte Negro was higher than that reported in developed countries. As expected, there was a progressive increase in the positivity for H. pylori in older age groups.

Este trabalho tem por objetivo analisar a soroprevalência do Helicobacter pylori, IgG, em população rural da Amazônia, e sua correlação com queixa dispéptica. No Projeto Bandeira Científica da FMUSP, em Monte Negro - RO, foram coletadas 266 amostras sangüíneas nos assentamentos rurais do município. Foram pesquisados anticorpos da classe IgG dirigidos contra Helicobacter pylori pelo método ELISA e aplicados questionários sobre dispepsia, aspectos sociais e epidemiológicos. Os pacientes tinham idades entre cinco e 81 anos (média de 34 anos); 149 (56 por cento) do sexo feminino e 117 (44 por cento) do sexo masculino. Foram encontradas 210 (78.9 por cento) amostras positivas, 50 negativas (18.8 por cento) e seis indeterminadas (2.3 por cento). A queixa de dispepsia foi encontrada em 226 casos (85.2 por cento). Não houve associação significativa entre os sintomas dispépticos e a soro positividade para H. pylori. Concluímos que a soro prevalência para todas as faixas etárias é comparável com os resultados de outros estudos realizados em países em desenvolvimento, e maior que aquela encontrada nos países desenvolvidos. Houve aumento progressivo da positividade com a idade, como citado na literatura.

Evaluation of Helicobacter pylory colonization by serologic test (IgG) and dyspepsia in volunteers from the countryside of Monte Negro, in the Brazilian western Amazon region.

The present study intended to analyze the seroprevalence of Helicobacter pylori, IgG, and its relation to dyspepsia in a population from the western Amazon region. During the "Projeto Bandeira Científica", a University of São Paulo Medical School program, in Monte Negro's rural areas, state of Rondônia, 266 blood samples were collected from volunteers. The material was tested for IgG antibodies anti-Helicobacter pylori by ELISA method and the participants were also interviewed on dyspepsia, hygiene and social aspects. Participants aged between five and 81 years old (34 years on average), 149 (56%) were female and 117 (44%) male. We found 210 (78.9%) positive, 50 (18.8%) negative and six (2.3%) undetermined samples. Dyspeptic complaints were found in 226 cases (85.2%). There was no statistical association between dyspepsia and positive serology for H. pylori. We concluded that the seroprevalence in all age categories is similar to results found in other studies conducted in developing countries, including those from Brazil. On the other hand, the seroprevalence found in Monte Negro was higher than that reported in developed countries. As expected, there was a progressive increase in the positivity for H. pylori in older age groups.

Avaliaçäo, em modelo experimental, da possibilidade do alopurinol impedir reativaçäo da infecçäo pelo Trypanosoma cruzi na vigência de imunodepressäo / Experimental model for the evaluation of the allopurinol as an agent to avoid the reactivation of Trypanosoma cruzi infection during immunodepression

Pacientes com a doença de Chagas na fase crônica têm sido tratados por meio de transplante de coraçäo, em determinadas circunstâncias, e em virtude de imunodepressäo pode ocorrer reativaçäo da infecçäo devida ao Trypanosoma cruzi. Foi verificado que o alopurinol mostrou-se apto a arrefecer esse acontecimento. Por isso, utilizando modelo experimental, procuramos verificar se tal fármaco é capaz de evitar a reativaçäo parasitária quando usado preventivamente. Verificamos, contudo, que propriedade dessa natureza näo ficou comprovada.

Prevalencia de toxoplasmose, leishmaniose, doenca de Chagas e enteroparasitoses em voluntarios da populacao de Cajati, estado de Sao Paulo, 1998 / Prevalence of toxoplasmosis, leishmaniosis, Chagas disease and intestinal parasitosis in volunteers from Cajati's population, state of Sao Paulo, 1998

Avaliamos a prevalencia de algumas doencas parasitarias no municipio de Cajati-SP (Vale do Ribeira), atraves da Bandeira Cientifica-1998, do Departamento Cientifico do Centro Academico Oswaldo Cruz, da Faculdade de Medicina da Universidade de Sao Paulo. Durante uma semana de intervencao, foram colhidas amostras em pacientes que buscaram ativamente um dos 3 postos de saude locais, englobando...