Logo do repositório
 
Publicação

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.

2013-02-27Artigo científico Acesso aberto
Ver registo simples
dc.contributor.authorKluge, Michael
dc.contributor.authorHegerl, Ulrich
dc.contributor.authorSander, Christian
dc.contributor.authorDietzel, Jens
dc.contributor.authorMergl, Roland
dc.contributor.authorBitter, Istvan
dc.contributor.authorDemyttenaere, Koen
dc.contributor.authorGusmão, Ricardo
dc.contributor.authorGonzalez-Pinto, Ana
dc.contributor.authorPerez-Sola, Victor
dc.contributor.authorVieta, Eduard
dc.contributor.authorJuckel, Georg
dc.contributor.authorZimmermann, Ulrich S
dc.contributor.authorBauer, Michael
dc.contributor.authorSienaert, Pascal
dc.contributor.authorQuintão, Sónia
dc.contributor.authorEdel, Marc-Andreas
dc.contributor.authorBolyos, Csilla
dc.contributor.authorAyuso-Mateos, Jose Luis
dc.contributor.authorLópez-García, Pilar
dc.contributor.institutionNOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
dc.contributor.institutionCentro de Estudos de Doenças Crónicas (CEDOC)
dc.contributor.pblBioMed Central (BMC)
dc.date.accessioned2017-07-10T22:00:28Z
dc.date.available2017-07-10T22:00:28Z
dc.date.issued2013-02-27
dc.description.abstractBACKGROUND: 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.Trial registration: ClinicalTrials.gov: NCT 01541605.en
dc.description.versionpublishersversion
dc.description.versionpublished
dc.format.extent9
dc.format.extent352702
dc.identifier.doi10.1186/1471-244X-13-71
dc.identifier.issn1471-244X
dc.identifier.otherPURE: 121248
dc.identifier.otherPURE UUID: d44b47f7-1f05-4667-a8cf-876fc53f732c
dc.identifier.otherresearchoutputwizard: 36806
dc.identifier.otherPubMed: 23446109
dc.identifier.otherWOS: 000315651500001
dc.identifier.otherScopus: 84874708766
dc.identifier.urihttp://hdl.handle.net/10362/21898
dc.language.isoeng
dc.peerreviewedyes
dc.subjectADULTS
dc.subjectCONTROLLED TRIAL
dc.subjectSLEEP
dc.subjectATTENTION-DEFICIT/HYPERACTIVITY-DISORDER
dc.subjectDEFICIT HYPERACTIVITY DISORDER
dc.subjectEEG-VIGILANCE
dc.subjectBipolar disorder
dc.subjectMethylphenidate
dc.subjectVigilance
dc.subjectBIPOLAR I DISORDER
dc.subjectMania
dc.subjectDEPRESSION
dc.subjectEXTENDED-RELEASE
dc.subjectEEG
dc.subjectRATING-SCALE
dc.subjectPsychostimulants
dc.subjectPsychostimulants
dc.subjectMania
dc.subjectBipolar disorder
dc.subjectMethylphenidate
dc.subjectVigilance
dc.subjectEEG
dc.titleMethylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.en
dc.typejournal article
degois.publication.firstPage71
degois.publication.issue1
degois.publication.lastPage80
degois.publication.titleBMC Psychiatry
degois.publication.volume13
dspace.entity.typePublication
rcaap.rightsopenAccess

Ficheiros

Principais
A mostrar 1 - 1 de 1
Miniatura
Nome:
1471-244X-13-71.pdf
Tamanho:
344.44 KB
Formato:
Adobe Portable Document Format
Ver/Abrir

Coleções

NMS: CEDOC - Artigos em revista internacional com arbitragem científica