Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED)

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 inbalance in dopamine and serotonin. This is a 6-week trial to test the efficacy and safety of asenapine, compared with placebo, using an active comparator agent (haloperidol) in the treatment of patients with an acute exacerbation of schizophrenia. Patients who complete the 6-week 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 Haloperidol 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: Asenapine
* Drug: Haloperidol
* Other: Placebo arm


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 pyschiatric 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 | Drug: Asenapine<br>* 5 mg BID<br>|
| Experimental: 2<br>Asenapine 10 mg BID | Drug: Asenapine<br>* 10 mg BID<br>|
| Active Comparator: 3<br>Haloperidol 4m mg BID | Drug: Haloperidol<br>* 4 mg BID<br>|
| Placebo Comparator: 4<br>placebo | Other: Placebo arm<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM) |  | Primary outcome measured weekly for 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I |  | At weekly intervals throughout the 6-week trial. | 
| Neurocognition and cognitive functioning |  | Baseline and Endpoint ( Day 42) | 
| CDSS |  | Days 21 and 42(Endpoint). | 
| Suicidal thinking ( ISST modified) |  | Days 14 and 42 (Endpoint) | 
| Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test |  | Baseline and Day 42(Endpoint) | 
| Readiness to discharge |  | At weekly intervals during the 6-week trial | 
| EPS ( AIMS; BARS; SARS) |  | At weekly intervals during the 6-week triaL | 
| Labs; Vital Signs; Weight and girth; ECG |  | Days 14; 28 and 42 (Endpoint) | 
| Safety and Tolerability |  |  |