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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
460
5 mg BID
10 mg BID
4 mg BID
Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM)
Time frame: Primary outcome measured weekly for 6 weeks
Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I
Time frame: At weekly intervals throughout the 6-week trial.
Neurocognition and cognitive functioning
Time frame: Baseline and Endpoint ( Day 42)
CDSS
Time frame: Days 21 and 42(Endpoint).
Suicidal thinking ( ISST modified)
Time frame: Days 14 and 42 (Endpoint)
Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test
Time frame: Baseline and Day 42(Endpoint)
Readiness to discharge
Time frame: At weekly intervals during the 6-week trial
EPS ( AIMS; BARS; SARS)
Time frame: At weekly intervals during the 6-week triaL
Labs; Vital Signs; Weight and girth; ECG
Time frame: Days 14; 28 and 42 (Endpoint)
Safety and Tolerability
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