Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED)
Status:
Completed
Trial end date:
2006-09-16
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.
Asenapine is an investigational drug that may help to correct the inbalance in dopamine and
serotonin. This is a 6-week trial to test the efficacy and safety of asenapine, compared with
placebo, using an active comparator agent (haloperidol) in the treatment of patients with an
acute exacerbation of schizophrenia. Patients who complete the 6-week trial will have the
option of continuing in an additional one year extension trial.