Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361166
Status:
COMPLETED
Last Update Posted:
2007-03-22
First Post:
2006-08-03
Brief Title:
Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
Sponsor:
ACADIA Pharmaceuticals Inc
Organization:
ACADIA Pharmaceuticals Inc
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None