Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)
Status:
Completed
Trial end date:
2013-10-07
Target enrollment:
Participant gender:
Summary
This study is designed to evaluate whether asenapine, which is approved by the United States
Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is
generally safe and well tolerated in adolescents with schizophrenia. This is an extension of
base study P05896 (NCT01190254), which means participants must have completed participation
in the 8-week base study in order to qualify for this extension study P05897. Participants in
this extension study will receive open-label asenapine for 26 weeks. Throughout the study,
observations will be made on each participant at various times to assess the long-term
safety, tolerability and efficacy of the study treatment.