A Randomized, Open-Label Study Comparing the Effectiveness of Olanzapine Pamoate Depot with Haloperidol Decanoate in the Treatment of Schizophrenia

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-003342-15

Femme et Homme

  • | Pays :
  • -
  • | Organes :
  • -
  • | Spécialités :
  • -

Extrait

The primary objective of this study is to evaluate whether OP Depot is superior to haloperidol decanoate in terms of overall effectiveness as measured by the time to all-cause discontinuation for up to 52 weeks in the treatment of symptomatic outpatients with schizophrenia who are at risk for relapse due to nonadherence, and who have previously had an unsatisfactory treatment response. Time to all-cause discontinuation is defined as the total number of days between the date of first depot dose (Visit 3) and the date of study discontinuation. Superiority of OP Depot treatment group will be assessed using the log-rank test from the Kaplan-Meier survival analysis.


Critère d'inclusion

  • Schizophrenia