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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
277
Asenapine 5-10mgBID
Matched against asenapine and olanzapine
10-20 mg QD
Change in total Positive and Negative Syndrome Scale (PANSS) score at endpoint (6-week double-blind or last assessment after baseline) from baseline
A 30-item, clinician rated instrument for assessing the symptoms of schizophrenia. Ratings for each item could range from 1 (absent) to 7 (extreme).
Time frame: Screen, baseline, days 4, 7, 14, 21, 28, 35, 42
Changes in PANSS subscale and Marder factor score Clinical Global Impression-Severity of Illness (CGI-S) scores
This was not a prespecified key secondary outcome
Time frame: Screen, baseline, Days 4,7,14,21,28,35,42
Clinical Global Impression Improvement (CGI-I) scores
This was not a prespecified key secondary outcome
Time frame: Days 4,7,14,21,28,35,42
Neurocognition and cognitive functioning
This was not a prespecified key secondary outcome
Time frame: Baseline , day 42
Anxiety
This was not a prespecified key secondary outcome
Time frame: Baseline, day 42
Suicidal thinking
This was not a prespecified key secondary outcome
Time frame: Baseline, day 42
Quality of life and patient functionality
This was not a prespecified key secondary outcome
Time frame: Baseline, day 42
Readiness to discharge, at scheduled assessments and endpoint from baseline
This was not a prespecified key secondary outcome
Time frame: Baseline up to day 14
Extrapyramidal symptoms
This was not a prespecified key secondary outcome
Time frame: Baseline, Days 4,7,14,21,28,35,42
Laboratory parameters
This was not a prespecified key secondary outcome
Time frame: Baseline, Days 14,,28,,42
Vital signs
This was not a prespecified key secondary outcome
Time frame: Baseline, Days ,14,21,28,42
Weight
This was not a prespecified key secondary outcome
Time frame: Baseline, Days 14,,28,,42
Electrocardiograms (ECGs)
This was not a prespecified key secondary outcome
Time frame: Baseline, Days ,14, 28, 42
Adverse events (including serious adverse events)
This was not a prespecified key secondary outcome
Time frame: Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 7 days after endpoint
Serious adverse events (SAEs) up to 30 days after endpoint
This was not a prespecified key secondary outcome
Time frame: Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 30 days after endpoint
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