Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)
Status:
Completed
Trial end date:
2013-04-01
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 also
effective in adolescents with schizophrenia. Participants who qualify for the study will be
randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily
[BID]) or placebo for 8 weeks. Throughout the study, observations will be made on each
participant at various times to assess the efficacy and safety of the study treatment. The
primary objective of the trial is to demonstrate significant superiority of at least one
asenapine dose to placebo, as measured by the change from baseline of the Positive and
Negative Syndrome Scale (PANSS) total score at Day 56.