Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
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 and well tolerated. Further purposes of this study are to determine whether
ACP-103, in combination with either haloperidol or risperidone, will enhance their
antipsychotic effectiveness, demonstrate effectiveness against the negative symptoms, improve
motoric tolerability, and is safe and well tolerated.
This is a seven-week study (one week screening and six weeks of study medication) where a
total of 400 patients who meet entrance criteria will randomly be assigned to receive one of
five groups of study treatments of either low dose haloperidol plus ACP-103, low dose
haloperidol plus placebo (a substance similar to a sugar pill), low dose risperidone plus
ACP-103, low dose risperidone plus placebo, or high dose risperidone plus placebo. The study
will begin with with a three to seven day drug-free period followed by six weeks of a stable
daily dosage of study medication. Study subjects will be treated as hospital in-patients
during screening and for the first 14 days of the study. Study subjects will be closely
monitored throughout the study.