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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Asenapine
* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: asenapine<br> | Drug: Asenapine<br>* 5-10 mg sublingually twice daily for up to 26 weeks<br>|
| Active Comparator: olanzapine<br> | Drug: Olanzapine<br>* 5-20 mg by mouth once daily for up to 26 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score | 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. | Day 182 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | 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. | Day 182 | 
| Change From Baseline in Body Weight |  | Day 182 |