Status:
COMPLETED
To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)
Lead Sponsor:
Organon and Co
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
831 Patients enrolled
Trial Details
Trial ID
NCT00150176
Start Date
April 1 2005
End Date
July 1 2008
Last Update
February 8 2022
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