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A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of licarbazepine 750-2000 mg/d as adjunctive therapy to lithium or valproate in the ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-000114-40

A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of licarbazepine 750-2000 mg/d as adjunctive therapy to lithium or valproate in the treatment of manic episodes of bipolar I disorder over 6 weeks

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Extrait

To demonstrate the efficacy of licarbazepine 750-2000 mg/d added to lithium or valproate in the treatment of manic episodes of bipolar I disorder by testing the following hypothesis: Licarbazepine added to lithium or valproate is superior to placebo combined with lithium or valproate 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 or mixed episodes

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