Status:
TERMINATED
Efficacy of Bifeprunox in Patients With Schizophrenia
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.
Detailed Description
Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. There are a number of antipsychotic drugs in use but none is ideal, in particular beca...
Eligibility Criteria
Inclusion
- Main inclusion criteria
- The subject has a primary diagnosis of schizophrenia
- The subject experiences clinically significant symptoms
- The subject's medication remained stable for 8 weeks prior to screening
- The subject is currently in the post-acute maintenance phase of his/her disease
Exclusion
- Main exclusion criteria
- The subject is at significant risk of suicide
- The subject is treatment resistant
- The subject has experienced an acute exacerbation within 8 weeks prior screening
- The subject is unlikely to comply with the protocol
- The subject has a current diagnosis or a history of substance abuse
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00658645
Start Date
March 1 2008
End Date
November 1 2009
Last Update
September 27 2010
Active Locations (38)
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1
BG002
Radnevo, Bulgaria, 6260
2
BG003
Radnevo, Bulgaria, 6260
3
CN009
Beijing, China, 100083
4
CN008
Beijing, China, 100088