drugset / Trial / NCT00212836

Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)

NCT00212836

Phase 3 Completed 481 enrolled Organon and Co
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, have shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.

Timeline

Start
2005-04-21
Primary completion
2007-06-15
Completion
2007-08-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Asenapine Other / unclassified 5 mg Other
Subject Asenapine Other / unclassified 10 mg Other
Comparator Olanzapine Small molecule 5 mg Oral
Comparator Olanzapine Small molecule 20 mg Oral

Indications