This study aims at evaluating the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.
Mania can be regarded as an autoregulatory mechanism to enhance unstable vigilance. There is increasing evidence that psychostimulants that increase vigilance may be effective in treating mania. However, controlled studies are lacking. This is a two-arm, randomised, placebo-controlled, double-blind, parallel, multi-centre phase IIIb exploratory study to evaluate the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
tablets for oral use
tablets for oral use
Katholieke Universiteit Leuven, campus Kortenberg
Kortenberg, Belgium
Universität Bochum
Bochum, Germany
Universität Dresden
Dresden, Germany
Universität Halle
Halle, Germany
manic symptoms as assessed by the Young Mania Rating Scale (YMRS)
Time frame: after 2.5 days of treatment
EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL)
Time frame: after 2.5 days of treatment
movements as assessed by actimetry
Time frame: after 2.5 days of treatment
cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP)
Time frame: after 2.5 days of treatment
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Universität Leipzig
Leipzig, Germany
Semmelweis University
Budapest, Hungary
Hospital Sant Pau
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Hospital Universitario la Princesa
Madrid, Spain
Hospital Santiago Apóstol
Vitoria-Gasteiz, Spain