Mania Clinical Trial
Official title:
International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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