Status:
COMPLETED
Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
Lead Sponsor:
ACADIA Pharmaceuticals Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to determine whether a combination of ACP-103 (the study medication) with either haloperidol or risperidone will show antipsychotic efficacy and that it is safe an...
Eligibility Criteria
Inclusion
- male or female subjects ages 18-65 diagnosed with schizophrenia
- experiencing an acute exacerbation of psychosis
- has had prior response to antipsychotic therapy within the previous 3 years
- female subjects must be of non-childbearing potential or must comply with double-barrier protection methods against conception
- ability of subject or caregiver or legally authorized representative to provide informed consent
- subjects must be hospitalized at screening and must be willing to remain in the hospital at least 14 days after baseline and must comply with all study events through completion of the study
Exclusion
- inability of the subject or caregiver or legally authorized representative to provide consent
- any female subject who is pregnant or breast feeding
- any subject with concurrent mental illness or disability
- any subject considered to be a danger to themselves or others
- recent use of certain antipsychotics or other medications that might interfere with this study's medication
- abnormal clinical laboratory values
- presence, or recent history, of serious medical conditions or drug abuse
- likely allergy or sensitivity to ACP-103, haloperidol, or risperidone, based on known allergies to drugs of the same class
- any subject who has participated in a prior clinical trial of ACP-103
- any subject judged by the Principal Investigator to be inappropriate for the study
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00361166
Start Date
August 1 2005
End Date
March 1 2007
Last Update
March 22 2007
Active Locations (17)
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1
Cerritos, California, United States, 90703
2
Garden Grove, California, United States, 92845
3
Glendale, California, United States, 91206
4
Paramount, California, United States, 90723