Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)

Study Overview
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Brief Summary
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Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. 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 is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.

Official Title
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A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine Positive Control in Subjects With an Acute Exacerbation of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: asenapine
* Drug: Placebo
* Drug: olanzapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently suffering from an acute exacerbation of schizophrenia. Caregiver required. Exclusion Criteria: Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.

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: 1<br>asenapine 5 mg BID and 10 mg BID | Drug: asenapine<br>* 5 mg BID or 10mg BID<br>|
| Placebo Comparator: 2<br>Placebo against olanzapine and asenapine | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: 3<br>olanzapine 15 mgQD | Drug: olanzapine<br>* olanzapine 15 mg QD<br>|

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 (6-week double-blind or last assessment after baseline) from baseline |  | Screen, baseline, Days 4,7,14,21,28,35,42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in PANSS subscale and Marder factor scores; CGI-S scores |  | Screen, baseline, Days 4,7,14,21,28,35,42 | 
| CGI-I scores |  | Days 4,7,14,21,28,35,42 | 
| Neurocognition and cognitive functioning |  | Baseline , day 42 | 
| Anxiety |  | Baseline, day 42 | 
| Suicidal thinking |  | Baseline, day 42 | 
| Quality of life and patient functionality |  | Baseline, day 42 | 
| Readiness to discharge, at scheduled assessments and endpoint from baseline |  | Baseline up to day 14 | 
| Extrapyramidal symptoms |  | Baseline, Days 4,7,14,21,28,35,42 | 
| Laboratory parameters |  | Baseline, Days 14,,28,,42 | 
| Vital signs |  | Baseline, Days ,14,21,28,42 | 
| Weight |  | Baseline, Days 14,,28,,42 | 
| ECGs |  | Baseline, Days ,14,,28,,42 | 
| Adverse events (including serious adverse events) |  | Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 7 days after endpoint | 
| SAEs up to 30 days after endpoint |  | Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 30 days after endpoint |