Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
460 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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