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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Unnamed facility
Cerritos, California, United States
Unnamed facility
Garden Grove, California, United States
Unnamed facility
Glendale, California, United States
Unnamed facility
Paramount, California, United States
Unnamed facility
Pico Rivera, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Austin, Texas, United States
...and 7 more locations
Total score on the Positive and Negative Symptom Scale (PANSS).
Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)
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