NCT00151424

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

A Multicenter, Randomized, Double-Blind, Flexible-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine Positive Control in Subjects With an Acute Exacerbation of Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	asenapine	Asenapine 5-10mgBID
DRUG	Placebo	Matched against asenapine and olanzapine
DRUG	Olanzapine	10-20 mg QD

Timeline

• Start date: 2005-02-15
• Primary completion: 2006-01-06
• Completion: 2006-02-06
• First posted: 2005-09-09
• Last updated: 2024-08-15