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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: asenapine; Drug: olanzapine

• Registration Number: NCT00212836
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-21
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2007-06-15
• Study Completion: 2007-08-02
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 481

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asenapine	asenapine	-
Olanzapine	olanzapine	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline at 6-months in Negative symptoms of schizophrenia measured by the Negative Symptoms Assessment (NSA) scale	Change from baseline at 6-months

Secondary Outcome Measures

Name	Time	Method
Change from baseline at 6-months in quality of life measured by the Quality of Life (QLS) scale	Change from baseline at 6-months
Positive and negative symptoms and other symptoms of schizophrenia e.g., hostility, excitement, disorganized thoughts and cognition measured by the Positive and Negative Symptom Scale (PANSS)	Change from baseline at 6-months
Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS)	Change from baseline at 6-months
Overall clinical global impression of severity improvement measured by the Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I)	Change from baseline at 6-months