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

被引:11
作者
Kluge, Michael [1 ]
Hegerl, Ulrich [1 ]
Sander, Christian [1 ]
Dietzel, Jens [1 ]
Mergl, Roland [1 ]
Bitter, Istvan [2 ]
Demyttenaere, Koen [3 ]
Gusmao, Ricardo [4 ]
Gonzalez-Pinto, Ana [5 ,6 ]
Perez-Sola, Victor [6 ,7 ]
Vieta, Eduard [6 ,8 ]
Juckel, Georg [9 ]
Zimmermann, Ulrich S. [10 ]
Bauer, Michael [10 ]
Sienaert, Pascal [3 ]
Quintao, Sonia [4 ]
Edel, Marc-Andreas [9 ]
Bolyos, Csilla [2 ]
Luis Ayuso-Mateos, Jose [6 ,11 ,12 ]
Lopez-Garcia, Pilar [6 ,12 ]
机构
[1] Univ Leipzig, Dept Psychiat & Psychotherapy, D-04103 Leipzig, Germany
[2] Semmelweis Univ, Dept Psychiat & Psychotherapy, H-1085 Budapest, Hungary
[3] Univ Psychiat Ctr KU Leuven, Dept Psychiat, Louvain, Belgium
[4] CEDOC, Clin Univ Psiquiatria & Saude Mental, Fac Ciencias Med Lisboa, Lisbon, Portugal
[5] Hosp Santiago Apostol, Dept Psychiat, Vitoria, Spain
[6] Ctr Invest Biomed Red Salud Mental CIBERSAM, Madrid, Spain
[7] Hosp Santa Creu & Sant Pau, Dept Psychiat, Barcelona, Spain
[8] Univ Barcelona, Dept Psychiat, IDIBAPS, Hosp Clin Barcelona, Barcelona, Spain
[9] Ruhr Univ Bochum, Dept Psychiat & Psychotherapy, Bochum, Germany
[10] Univ Hosp Dresden, Dept Psychiat & Psychotherapy, Dresden, Germany
[11] Univ Autonoma Madrid, Dept Psychiat, Madrid, Spain
[12] Inst Invest Sanitaria Princesa IP, Madrid, Spain
关键词
Psychostimulants; Mania; Bipolar disorder; Methylphenidate; Vigilance; EEG; ATTENTION-DEFICIT/HYPERACTIVITY-DISORDER; DEFICIT HYPERACTIVITY DISORDER; BIPOLAR I DISORDER; EXTENDED-RELEASE; CONTROLLED TRIAL; EEG-VIGILANCE; RATING-SCALE; SLEEP; DEPRESSION; ADULTS;
D O I
10.1186/1471-244X-13-71
中图分类号
R749 [精神病学];
学科分类号
100205 ;
摘要
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.
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页数:9
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