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A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of licarbazepine 750-2500 mg/d combined with risperidone in the treatment of manic e...

Mise à jour : Il y a 5 ans
Référence : EUCTR2004-000113-18

A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of licarbazepine 750-2500 mg/d combined with risperidone in the treatment of manic episodes of bipolar I disorder over 6 weeks

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Extrait

To demonstrate the efficacy of licarbazepine 750-2500 mg/d combined with risperidone in the treatment of manic episodes of bipolar I disorder by testing the following hypothesis: Licarbazepine combined with risperidone is superior to placebo combined with risperidone in the reduction of the mean total score of the Young Mania Rating Scale (Y-MRS) from baseline to endpoint (Week 6).

Critère d'inclusion

  • Bipolar I disorder, manic and mixed episodes

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