A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study)

• Tipo: Artigo em Revista Científica Internacional
• Data: 2018

Autores

Hegerl, U (Autor) Outra; Mergl, R (Autor) Outra; Sander, C (Autor) Outra; Dietzel, J (Autor) Outra; Bitter, I (Autor) Outra; Demyttenaere, K (Autor) Outra; Gusmao, R (Autor) Outra; Arrillaga, AGP (Autor) Outra; Zorrilla, I (Autor) Outra; Alocen, AG (Autor) Outra; Sola, VP (Autor) Outra; Vieta, E (Autor) Outra; Juckel, G (Autor) Outra; Zimmermann, US (Autor) Outra; Bauer, M (Autor) Outra; Sienaert, P (Autor) Outra; Quintao, S (Autor) Outra; Edel, MA (Autor) Outra; Bolyos, C (Autor) Outra; Ayuso Mateos, JL (Autor) Outra; Lopez Garcia, P (Autor) Outra; Kluge, M (Autor) Outra

Revista

Título: European Neuropsychopharmacology

Vol. 28

Páginas: 185-194

ISSN: 0924-977X

Editora: Elsevier

Indexação

ISI Web of Knowledge - 1 Citação

Scopus - 3 Citações

Outras Informações

ID Authenticus: P-00N-FJN

DOI: 10.1016/j.euroneuro.2017.11.003

Abstract (EN): Based on many clinical and preclinical findings the 'vigilance regulation model of mania' postulates that an unstable regulation of wakefulness is a pathogenetic factor in both mania and Attention Deficit Hyperactivity Disorder (ADHD) and induces hyperactivity and sensation seeking as an autoregulatory attempt to stabilize wakefulness. Accordingly, stimulant medications with their vigilance stabilizing properties could have rapid antimanic effects similar to their beneficial effects in ADHD. The MEMAP study- a multi-center, double-blind, placebo-controlled and randomized clinical trial (RCT)- assessed the antimanic efficacy and safety of a 2.5-day treatment with methylphenidate (20-40 mg/day). Of 157 screened patients with acute mania, 42 were randomly assigned to receive 20-40 mg per day of methylphenidate in one or two applications, or placebo. The primary outcome was the change in Young Mania Rating Scale (YMRS) sum scores from baseline to day 2.5 in the methylphenidate group compared to the placebo group. A group sequential design was chosen to justify early RCT termination based on efficacy or futility at an interim analysis after inclusion of 40 patients. In the interim analysis, the change from baseline in the YMRS total score at day 2.5 was not significantly different between both groups (F(1,37)=0.23; p= 0.64). Thus, futility was declared for methylphenidate and the RCT was stopped. In summary, although methylphenidate was well tolerated and safe in the full analysis set, it failed to show efficacy in the treatment of acute mania. Trial registration: clinicaltrials.gov (URL: http://vvww.ctinicattriats.gov; registration number: NCT01541605).

Idioma: Inglês

Tipo (Avaliação Docente): Científica

Nº de páginas: 10