Status:
COMPLETED
Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)
Lead Sponsor:
Organon and Co
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 fr...
Eligibility Criteria
Inclusion
- Completed the short-term 041023 trial (NCT00156104)
- Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial
- Sign a written informed consent for the 041513 trial.
- Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator
Exclusion
- CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic)
- Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation
- Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial
- Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00156065
Start Date
September 1 2005
End Date
October 1 2007
Last Update
February 8 2022
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