Long-Term Efficacy and Safety of Asenapine Using Olanzapine as a Positive Control (41512)(COMPLETED)(P05784)
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by
Positive symptoms (symptoms that should not be there, inability to think clearly, to
distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or
absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and
relate to others). Other symptoms include reduced ability to recall and learn new
information, difficulty with problem solving, or maintaining productive employment. The
symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily
dopamine and serotonin, which enables brain cells to communicate with each other.
The clinical development of asenapine, as described in the 2007 IDB appears to have
antipsychotic activity with superior symptomatic control compared to placebo and an improved
safety profile compared to currently available neuroleptics. Its fast dissolving formulation
may further add to treatment compliance. While various titration schedules have been used in
previous studies, dose increases at 5 mg BID up to 10 mg BID have been well tolerated.
Therefore, further exploration in a larger group of subjects with acute exacerbation of
schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual
clinical practice in a long-term 52-week extension trial.