A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750-2000 mg/d in the treatment of manic episodes of bipolar I disorder

Update Il y a 4 ans
Reference: EUCTR2004-000687-27

Woman and Man

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Extract

To assess the safety and tolerability of open-label treatment with licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2303, with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.


Inclusion criteria

  • Bipolar I disorder, manic and mixed episodes