84 research outputs found

    Adjuvant therapy with minocycline for schizophrenia (The MINOS Trial): study protocol for a double-blind randomized placebo-controlled trial

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    Background: Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom dimensions. The negative symptom dimension, with its protean cognitive manifestations, responds poorly to treatment, which can be a particular challenge in countries where clozapine therapy is not available. Preliminary data indicate that minocycline may be beneficial adjunct in the treatment of schizophrenia: positive, negative, and cognitive symptoms. In this study we aim to assess the efficacy of adjunctive minocycline to alleviate symptoms of schizophrenia in patients who have failed to respond to a therapeutic trial of antipsychotic medications. Methods: The study is a parallel group, double-blind, randomized, placebo-controlled trial. Participants will be adults (aged 18 years and above) with first episode or relapse episode of schizophrenia of under 5 years’ duration. Patients who failed to show adequate therapeutic response to at least one antipsychotic medication given for a minimum of 4 weeks will be recruited from a psychiatry hospital in Addis Ababa and a psychiatry clinic in Butajira, Ethiopia. A total of 150 participants (75 in each arm) will be required to detect a five-point mean difference between the intervention arms adjusting for baseline symptom severity, at 90% power and 95% confidence. Patients in the intervention arm will receive minocycline (200 mg/day orally) added on to the regular antipsychotic medications participants are already on. Those in the placebo arm will receive an inactive compound identical in physical appearance to minocycline. Intervention will be offered for 12 weeks. Diagnosis will be established using the operational criteria for research (OPCRIT). Primary outcome measure will be a change in symptom severity measured using the positive and the negative syndrome scale for schizophrenia (PANSS). Secondary outcome measures will include changes in severity of negative symptoms, proportion achieving remission, and level of functioning. Whether changes are maintained post intervention will also be measured (PANSS). Key assessment for the primary outcome will be conducted at the end of trial (week 12). One post-intervention assessment will be conducted 4 weeks after the end of intervention (week 16) to determine sustainability of change. Trial registration Clinicaltrials.gov identifier: NCT01809158

    Impactos da microcefalia no brasil e no mundo: revisão sistemática e meta-análise/ Impacts of microcephaly in brazil and the world: systematic review and meta-analysis

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    A microcefalia apresenta etiologia complexa e multifatorial, sendo identificada pela medida do Perímetro Cefálico (PC) menor que dois desvios-padrões da média específica para o sexo e idade gestacional. A infecção trouxe diversas consequências psicossociais e econômicas. Portanto, é de fundamental importância a compreensão dos impactos gerados no Brasil e no mundo. O objetivo do estudo é conhecer os impactos da microcefalia no Brasil e no mundo. Trata-se de um estudo de revisão sistemática seguida de metanálise. O período de busca foi realizado durante o mês de junho de 2020, contemplando os artigos das bases de dados: PUBMED, SCOPUS e Web of Science. Utilizou-se artigos nos idiomas inglês, português e espanhol, com período de publicação dos últimos 5 anos (2015-2020), utilizando os descritores em MESH: Microcephaly, “Zika Virus”, “Health Impact Assessment”, fazendo uso do operador booleano AND. A análise apresenta um efeito final de 0,79 com IC de 0,66 a 0,88 o que representa um tamanho de efeito médio pela interpretação estatística. Portanto, é crucial compreender os impactos que patologia gera, para que assim sejam implementadas mais políticas públicas voltadas para melhora da qualidade de vida dos pacientes e família, assim como para a sociedade como um todo
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