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A Randomized, Double Blind, Multi-Center Study to Assess the Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol or Risperidone to Schizophrenic Subjects
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Cerritos, California, United States
Garden Grove, California, United States
Glendale, California, United States
Paramount, California, United States
Pico Rivera, California, United States
San Diego, California, United States
San Diego, California, United States
Washington D.C., District of Columbia, United States
St Louis, Missouri, United States
Austin, Texas, United States
Start Date
August 1, 2005
Completion Date
March 1, 2007
Last Updated
March 22, 2007
400
Estimated participants
ACP-103
DRUG
Lead Sponsor
ACADIA Pharmaceuticals Inc.
NCT07455929
NCT06740383
Data Source & Attribution
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