Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846)

Study Overview
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Brief Summary
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The primary features of schizophrenia and schizoaffective disorder are positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving maintaining productive employment. Asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.

Official Title
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Long-Term Efficacy and Safety Evaluation of Asenapine (10-20 mg/Day) in With Schizophrenia or Schizoaffective Disorder, in a Multicenter Trial Using (10-20 mg/Day) as a Control

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: asenapine
* Drug: olanzapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with schizophrenia or schizoaffective disorder. Must have completed 12 months treatment under protocol 25517. Subject must sign a written informed consent. Exclusion Criteria: Have an uncontrolled, unstable, clinically significant medical condition.

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: Arm 1<br> | Drug: asenapine<br>* Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.<br>* Other names: SCH 900274;|
| Active Comparator: Arm 2<br> | Drug: olanzapine<br>* Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.<br>* Other names: Zyprexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total PANSS score at endpoint |  | Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in PANSS subscale scores and Marder factor scores |  | Every 24 weeks after baseline | 
| Changes in CGI-S |  | Every 12 weeks after baseline | 
| Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN) |  | Every 48 weeks after baseline | 
| Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia) |  | Every 24 weeks after baseline | 
| Resource utilization (as measured by frequency and length of hospital stay) |  | During the entire study period | 
| Safety and tolerability: EPS (AIMS, BARS, SARS) |  | Every 24 weeks after baseline | 
| Adverse Events |  | Continuously and up to 7 days after endpoint | 
| Pregnancy Test |  | At endpoint | 
| Blood Tests |  | Every 12 weeks after baseline | 
| Weight and vital signs |  | Every 4 weeks after baseline | 
| ECGs |  | Every 24 weeks after baseline |