NCT00145496

Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)

A Multicenter, Double-Blind, Flexible -Dose, 6-Month Trial Comparing the Efficacy and Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 468 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, has 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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Asenapine	5-10 mg sublingually twice daily for up to 26 weeks
DRUG	Olanzapine	5-20 mg by mouth once daily for up to 26 weeks

Timeline

• Start date: 2004-12-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2005-09-05
• Last updated: 2022-02-08
• Results posted: 2010-03-25