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An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium versus Placebo as an add on to SEROQUEL XR™ (Quetiapine Fumarate) in A...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-007190-20

An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium versus Placebo as an add on to SEROQUEL XR™ (Quetiapine Fumarate) in Adult Patients with Acute Mania

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Extrait

The primary objective is to evaluate the effectiveness of lithium compared to placebo as an add on to quetiapine XR in the treatment of acute mania in subjects with bipolar I disorder, as assessed by the change from baseline to final assessment (Day 43) in Young Mania Rating Scale (YMRS) total score.

Critère d'inclusion

  • Acut mania in subjects with bipolar I disorder

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