Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.

BACKGROUND: Treatment of patients with acute mania remains a considerable medical challenge since onset of action of antimanic medication is delayed for several days. Psychostimulants could have an earlier onset of action. This assumption is based on the 'vigilance regulation model of mania' which postulates that vigilance is unstable in manic patients. Accordingly, vigilance-stabilising psychostimulants could be more useful than conventional treatment in acute mania. We present here the study protocol of a trial intended to study the efficacy and safety of methylphenidate in the initial treatment of acute mania. METHODS/DESIGN: A multi-centre, randomised, double-blind, placebo-controlled clinical trial will be conducted in 88 bipolar inpatients with acute mania. Male and female patients older than 18 years will be randomised to treatment with either methylphenidate (20 to 40 mg/day) or placebo for 2.5 days, given once or twice daily. The main outcome measure is the reduction in the Young Mania Rating Scale (YMRS) after 2.5 days of treatment. Other outcome measures include the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) the Clinical Global Impression-Bipolar Scale (CGI-BP), the Screen for Cognitive Impairment in Psychiatry (SCIP), actigraphy and the EEG-'Vigilance Algorithm Leipzig' (VIGALL). DISCUSSION: A positive study outcome of the proposed study could substantially impact our understanding of the etiopathogenesis of mania and open new treatment perspectives

Prevalência de respiradores bucais em crianças de idade escolar Prevalence of mouth breathing in children from an elementary school

Pretende-se identificar a prevalência de respiradores bucais em crianças de uma escola do ensino fundamental. Foram aplicados 496 questionários aos pais ou responsáveis das crianças de 1ª à 4ª série de uma escola fundamental, para identificar respiradores bucais. O questionário incluía questões sobre hábitos, sono, comportamento, alimentação, cuidados pessoais e respiração. Para comparar as variáveis entre respiradores bucais e nasais, foi utilizado o teste de Mann-Whitney e qui-quadrado. Para medir o efeito da exposição das variáveis explicativas sobre o desfecho primário, foi utilizada regressão logística e sua magnitude foi calculada por meio do odds ratio. A significância estatística foi estipulada em 5%. A taxa de devolução dos questionários foi de 84,5%. A prevalência de respiração bucal nessa população foi 56,8%. A mediana de idade foi sete anos (6-9). Não houve diferença estatisticamente significante entre os gêneros, 49,1% masculino e 50,9% feminino. O modelo final de regressão logística identificou as variáveis baba, dorme bem (associação negativa) e ronca como fatores que predizem a ocorrência da respiração bucal. A prevalência de respiradores bucais foi semelhante à encontrada na literatura pesquisada. As variáveis babar, roncar e dormir bem (associação negativa) podem predizer a ocorrência da respiração bucal.<br>The objective of this article is to identify the prevalence of mouth breathing in children from an elementary school. 496 questionnaires were answered by 1st and 4th grade children's parents or sponsors in order to identify mouth-breathing. There were questions about habits, sleeping, behavior, eating, personal care and breathing. Mann-Whitney and the Chi-square tests were used to compare the variables between mouth-breathing and nose-breathing among the groups. To measure the exposure effect of the explanatory variables on mouse breathing, the test of logistic regression was used and its magnitude was calculated through Odds Ratio. The statistical significance was set at 5%, and the rate of returned questionnaires was 84.5%. The prevalence of the mouthbreathing over this population was 56.8%. The average age was 7 years old (6-9). There was no significant statistical difference between genders, considering 49.1% male and 50.9% female. The final model of logistic regression identified the variables dribble, sleeps well (negative association) and snores as factors that predict the occurrence of the mouth-breathing. The prevalence of mouthbreathing was similar to related in the literature. The variables dribble, sleeps well (negative association) and snores may be factors that predict the occurrence of mouth-breathing