To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.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 may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
- Have a primary diagnosis of schizophrenia
- History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening
- History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening
- Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms
Key Exclusion Criteria:
- Have an uncontrolled, unstable clinically significant medical condition
- History of suicide attempt or significant violence to others in the past 2 years
- A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
- Current substance abuse/dependence
- Concurrent psychiatric disorder other than schizophrenia.
Trial design
Primary purpose
Allocation
Interventional model
Masking
831 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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