To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)

Study Overview
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Brief Summary
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Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.

Official Title
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A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Asenapine - Open Label
* Drug: Placebo - Double Blind
* Drug: Asenapine - Double Blind


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Have a primary diagnosis of schizophrenia History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms Key Exclusion Criteria: Have an uncontrolled, unstable clinically significant medical condition History of suicide attempt or significant violence to others in the past 2 years A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse Current substance abuse/dependence Concurrent psychiatric disorder other than schizophrenia.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: asenapine<br> | Drug: Asenapine - Open Label<br>* Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).<br>* Other names: Saphris, Org 5222, SCH 900274;Drug: Asenapine - Double Blind<br>* Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.<br>* Other names: Org 5222, SCH 900274, Saphris;|
| Placebo Comparator: placebo<br> | Drug: Asenapine - Open Label<br>* Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).<br>* Other names: Saphris, Org 5222, SCH 900274;Drug: Placebo - Double Blind<br>* Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Relapse or an Impending Relapse | A relapse or impending relapse was declared if a subject meets 1 of 3 symptomatic relapse criteria which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary. | time of first relapse up to Day 182 (double blind phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Early Discontinuation for Any Reason | The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse). | time of discontinuation up to Day 182 (double blind phase) |