A Study to Evaluate the Efficacy and Safety of Seroquel in Chinese Han Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Quetiapine; risperidone
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Seroquel; Risperdal
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; antipsychotics; quetiapine; risperidone; efficacy; safety; multicenter; rater-blind; randomized; chinese; han