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

• Status: Completed
• Trial end date: 2007-08-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Asenapine; Olanzapine

Criteria

Inclusion Criteria:

• Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.

• No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.

• Caregiver required.

Exclusion Criteria:

• Have an uncontrolled, unstable clinically significant medical condition.

• Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.