A Study to Evaluate the Efficacy and Safety of Seroquel in Chinese Han Patients With Schizophrenia
The primary objective of this study is to evaluate the efficacy of seroquel in the treatment of patients with acute schizophrenia compared with risperidone by evaluating the change of PANSS total score from the baseline to week 6.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A 6-Week, Multicenter, Rater-blind, Randomized, Risperidone-controlled Study to Evaluate the Efficacy and Safety of Seroquel (Quetiapine Fumarate) in the Treatment of Chinese Han Patients With Schizophrenia|
- the change of PANSS total score [ Time Frame: from the baseline to week 6 ] [ Designated as safety issue: No ]
- The Carlgary depression scale for schizophrenia (CDSS) [ Time Frame: from the baseline to week 6 ] [ Designated as safety issue: No ]
- The abnormal involuntary movement scale (AIMS) [ Time Frame: from the baseline to Week 6 ] [ Designated as safety issue: Yes ]
- The Simpson and Angus scale (SAS) [ Time Frame: from the baseline to week 6 ] [ Designated as safety issue: Yes ]
- The clinical global impression (CGI),including CGI-I and CGI-S [ Time Frame: from the baseline to week 6 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Quetiapine fumarate, flexible doses(600-750 mg/d)
Quetiapine fumarate, 25mg/200 mg, the dose titration is carried in week 1. flexible doses(600-750 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator.
Other Name: Seroquel
Active Comparator: 2
risperidone, flexible doses(3-6 mg/d)
risperidone, 1mg/tablet, the dose titration is carried in week 1. flexible doses(3-6 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator.
Other Name: Risperdal
This is a rater- blind, parallel assignment, randomized and active controlled study. The subjects investigated are outpatients or inpatient with schizophrenia from the Chinese Han race. The screening phase lasts for 1 week. The eligible patients enter the next randomized treatment phase. The titration duration is 1 week. After the first week, the patients are administered with a flexible dose regimen. In this study, the effective doses range of seroquel and risperidone are 600-750mg/d and 3-6mg/d respectively and the treatment duration lasts for 6 weeks.
The efficacy and safety of seroquel in the treatment of patients with schizophrenia have been confirmed by multiple double blind studies. This study is designed to evaluate the efficacy and safety of seroquel in the treatment of Chinese Han patients with schizophrenia. Therefore, the single blind and active control design should be selected for this study. The drug titration method and dose are within the range specified in the instruction and patients with schizophrenia are tolerant to the drug in clinical treatment.
The purpose of schizophrenic patient treatment is to improve the core symptoms, prevent suicide and other aggressive behavior, alleviate the side reactions caused by the drug, and recover the life functions of patients. Generally, the treatment in the acute phase lasts for 6 to 8 weeks. In this study, the treatment in the acute phase lasts for 6 weeks.
The rating scales used in this study are standard psychiatric rating scales with good validity and are widely used in the study of antischizophrenia drugs and in the treatment of patients with schizophrenia in China. The PANSS is developed from two early rating scales, namely the brief psychiatric rating scale (BPRS) and the psychiatric rating scale. The high inter-investigator reliability and repeated measurement reliability of these scales have been proved by multiple studies. The clinical global impression (CGI) is a simple but convenient global impression scale. It is applicable to any patients treated and studied by the psychiatric department. The Carlgary depression scale for schizophrenia (CDSS) is used to evaluate the depressive symptoms of patients with schizophrenia. It has good reliability and validity. The abnormal involuntary movement scale (AIMS) is another evaluation tool consisting of 12 items. The AIMS is used to evaluate the abnormal involuntary movements related to antischizophrenia drugs. The AIMS is nearly the most frequently used multi-item rating scale evaluating of tardive dyskinesia. The Simpson and Angus scale (SAS) is also a rating scale commonly used since its release in 1970. The validity of SAS has been verified in the double blind and placebo-controlled study involving two haloperidol doses.
|Shanghai Mental Health Center|
|Shanghai, Shanghai, China, 200030|
|Branch Hospital of Shanghai Mental Health Center|
|Shanghai, Shanghai, China, 201108|
|Mental Health Center of Luwan District|
|Shanghai, Shanghai, China, 200020|
|Huzhou Third People Hospital|
|Huzhou, Zhejiang, China, 313000|
|Principal Investigator:||Huafang LI, MD,PhD||Drug Clinical Trial Office, Shanghai Mental Health Center|