Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202007
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2005-09-12
Brief Title:
Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia
Sponsor:
Otsuka Beijing Research Institute
Organization:
Otsuka Beijing Research Institute
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Study Comparing With Risperidone to Evaluate the Efficacy and Safety of Aripiprazole in the Treatment of Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study design is subject to relevant SFDA regulations about clinical trials Patients will be screened for inclusion into the study at the initial visit240 patients to be recruited and then undergo a minimum of 3-7 days placebo washout periodplacebo wash out is to eliminate the effect of prior antipsychotic medication with tablets without any active ingredientspatients without prior antipsychotic medication are exempt from the washout phase After screening and washout period eligible patients will be randomly assigned to the two treatment group Aripiprazole or Risperidone for 6 weeks treatment Patients will be hospitalized for the entire duration of the study Patients condition will be assessed weekly
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