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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Asenapine; Drug: Olanzapine

• Registration Number: NCT00145496
• 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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Disposition First Submitted: 2009-04-17
• Disposition First Submitted QC: 2009-10-02
• Disposition First Posted: 2009-10-06
• Results First Submitted: 2010-03-05
• Results First Submitted QC: 2010-03-05
• Results First Posted: 2010-03-25
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 468

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.

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Exclusion Criteria

• Have an uncontrolled, unstable clinically significant medical condition.
• Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
asenapine	Asenapine	-
olanzapine	Olanzapine	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score	Day 182	The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 to 96, with greater scores indicating greater severity of symptoms.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score	Day 182	The Quality of Life Scale is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 to 126, with greater values indicating better quality of life.
Change From Baseline in Body Weight	Day 182