Suchergebnisse

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. ; The study is supported by a grant of the Spanish 'Ministerio de Sanidad, Politica Social e Igualdad' (Ministry of Health, Social Politics and Equality) which was provided after a peer review process and by the Instituto de Salud Carlos III of Spain. Study drug is kindly provided by Medice, Iserlohn, Germany. Training videos for training on the YMRS are kindly provided by Bracket, Wayne, USA

Funding for the mhGAP Programme, under which the work reported in this manuscript was done, was provided by the following: American Psychiatric Foundation, USA; Association of Aichi Psychiatric Hospitals, Japan; Autism Speaks, USA; CBM; Government of Italy; Government of Japan; Government of The Netherlands; International Bureau for Epilepsy; International League Against Epilepsy; Medical Research Council, UK; National Institute of Mental Health, USA; Public Health Agency of Canada, Canada; Rockefeller Foundation, USA; Shirley Foundation, UK; Syngenta, Switzerland; United Nations Population Fund;World Psychiatric Association

Despite the high impact of mental disorders in society, European mental health research is at a critical situation with a relatively low level of funding, and few advances been achieved during the last decade. The development of coordinated research policies and integrated research networks in mental health is lagging behind other disciplines in Europe, resulting in lower degree of cooperation and scientific impact. To reduce more efficiently the burden of mental disorders in Europe, a concerted new research agenda is necessary. The ROAMER (Roadmap for Mental Health Research in Europe) project, funded under the European Commission's Seventh Framework Programme, aims to develop a comprehensive and integrated mental health research agenda within the perspective of the European Union (EU) Horizon 2020 programme, with a translational goal, covering basic, clinical and public health research. ROAMER covers six major domains: infrastructures and capacity building, biomedicine, psychological research and treatments, social and economic issues, public health and well‐being. Within each of them, state‐of‐the‐art and strength, weakness and gap analyses were conducted before building consensus on future research priorities. The process is inclusive and participatory, incorporating a wide diversity of European expert researchers as well as the views of service users, carers, professionals and policy and funding institutions. Copyright © 2013 John Wiley & Sons, Ltd.