Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(P05947)

NCT00151424 PHASE3 COMPLETED

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 imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.

Details

Lead sponsor	Organon and Co
Phase	PHASE3
Status	COMPLETED
Enrolment	277
Start date	Tue Feb 15 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Feb 06 2006 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Schizophrenia

Interventions

• asenapine
• Placebo
• Olanzapine