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A Study to Evaluate the Efficacy and Safety of Seroquel in Chinese Han Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Quetiapine

risperidone

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, antipsychotics, quetiapine, risperidone, efficacy, safety, multicenter, rater-blind, randomized, chinese, han

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent provided by legal guardians or patients.
Patients who met DSM-IV criteria for schizophrenia: 295.20 (Schizophrenia, Catatonic Type), 295.10 (Schizophrenia, Disorganized Type), 295.30 (Schizophrenia, Paranoid Type), 295.60 (Schizophrenia, Residual Type), and 296.90 (Mood Disorder NOS).
Age from 18-65 years old, male or female, Han nationality.
PANSS total score at least 70 at baseline.
Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
Able to understand and comply with the requirements of the study. -

Exclusion Criteria:

Pregnancy or lactation.
A diagnosis of any DSM-IV Axis I disorders that is not defined in the inclusion criteria, except schizophrenia.
Patients who have an imminent risk of suicide or a danger to self or others as judged by investigator.
Known intolerance or lack of efficacy to seroquel and/or risperidone, as judged by the investigator.
Use of seroquel and/or risperidone within 28 days prior to enrolment.
Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir.
Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids.
Use of a long acting antipsychotics Within one dosing interval
Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse as defined by DSM-IV criteria within 28 days prior to enrolment.
Medical conditions that would affect the absorption, distribution, metabolism, or excretion of study treatment.
Unstable or inadequately treated medical illness (e.g. CHF - congestive heart failure, angina pectoris, hypertension) as judged by the investigator.
Involvement in the planning and conduct of the study.
Participation in another drug trial within 28 days prior enrolment into this study.
Patient with diabetes mellitus.
The patient's absolute neutrophil count (ANC) ≤ 1.5 x 109/L and the ALT and AST values in the liver function test exceeding two times of the upper limits of normal values.
Use of Electroconvulsive therapy within 28 days prior to randomization.
Use of clozapine within 28 days prior to randomization.
Previous enrolment in the present study -

Sites / Locations

Mental Health Center of Luwan District
Shanghai Mental Health Center
Branch Hospital of Shanghai Mental Health Center
Huzhou Third People Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Quetiapine fumarate, flexible doses(600-750 mg/d)

risperidone, flexible doses(3-6 mg/d)

Outcomes

Primary Outcome Measures

the change of PANSS total score

Secondary Outcome Measures

The Carlgary depression scale for schizophrenia (CDSS)

The abnormal involuntary movement scale (AIMS)

The Simpson and Angus scale (SAS)

The clinical global impression (CGI),including CGI-I and CGI-S

Full Information

NCT ID

NCT00817648

First Posted

January 5, 2009

Last Updated

June 11, 2010

Sponsor

Shanghai Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT00817648

Brief Title

A Study to Evaluate the Efficacy and Safety of Seroquel in Chinese Han Patients With Schizophrenia

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Shanghai Mental Health Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

schizophrenia, antipsychotics, quetiapine, risperidone, efficacy, safety, multicenter, rater-blind, randomized, chinese, han

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Quetiapine fumarate, flexible doses(600-750 mg/d)

Arm Title

Arm Type

Active Comparator

Arm Description

risperidone, flexible doses(3-6 mg/d)

Intervention Type

Drug

Intervention Name(s)

Quetiapine

Other Intervention Name(s)

Seroquel

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

risperidone

Other Intervention Name(s)

Risperdal

Intervention Description

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.

Primary Outcome Measure Information:

Title

the change of PANSS total score

Time Frame

from the baseline to week 6

Secondary Outcome Measure Information:

Title

The Carlgary depression scale for schizophrenia (CDSS)

Time Frame

from the baseline to week 6

Title

The abnormal involuntary movement scale (AIMS)

Time Frame

from the baseline to Week 6

Title

The Simpson and Angus scale (SAS)

Time Frame

from the baseline to week 6

Title

The clinical global impression (CGI),including CGI-I and CGI-S

Time Frame

from the baseline to week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent provided by legal guardians or patients. Patients who met DSM-IV criteria for schizophrenia: 295.20 (Schizophrenia, Catatonic Type), 295.10 (Schizophrenia, Disorganized Type), 295.30 (Schizophrenia, Paranoid Type), 295.60 (Schizophrenia, Residual Type), and 296.90 (Mood Disorder NOS). Age from 18-65 years old, male or female, Han nationality. PANSS total score at least 70 at baseline. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment. Able to understand and comply with the requirements of the study. - Exclusion Criteria: Pregnancy or lactation. A diagnosis of any DSM-IV Axis I disorders that is not defined in the inclusion criteria, except schizophrenia. Patients who have an imminent risk of suicide or a danger to self or others as judged by investigator. Known intolerance or lack of efficacy to seroquel and/or risperidone, as judged by the investigator. Use of seroquel and/or risperidone within 28 days prior to enrolment. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids. Use of a long acting antipsychotics Within one dosing interval Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse as defined by DSM-IV criteria within 28 days prior to enrolment. Medical conditions that would affect the absorption, distribution, metabolism, or excretion of study treatment. Unstable or inadequately treated medical illness (e.g. CHF - congestive heart failure, angina pectoris, hypertension) as judged by the investigator. Involvement in the planning and conduct of the study. Participation in another drug trial within 28 days prior enrolment into this study. Patient with diabetes mellitus. The patient's absolute neutrophil count (ANC) ≤ 1.5 x 109/L and the ALT and AST values in the liver function test exceeding two times of the upper limits of normal values. Use of Electroconvulsive therapy within 28 days prior to randomization. Use of clozapine within 28 days prior to randomization. Previous enrolment in the present study -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huafang LI, MD,PhD

Organizational Affiliation

Drug Clinical Trial Office, Shanghai Mental Health Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mental Health Center of Luwan District

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200020

Country

China

Facility Name

Shanghai Mental Health Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

Branch Hospital of Shanghai Mental Health Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201108

Country

China

Facility Name

Huzhou Third People Hospital

City

Huzhou

State/Province

Zhejiang

ZIP/Postal Code

313000

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

12408887

Citation

Mandrioli R, Fanali S, Ferranti A, Raggi MA. HPLC analysis of the novel antipsychotic drug quetiapine in human plasma. J Pharm Biomed Anal. 2002 Nov 7;30(4):969-77. doi: 10.1016/s0731-7085(02)00395-3.

Results Reference

background

PubMed Identifier

10704032

Citation

Davis PC, Wong J, Gefvert O. Analysis and pharmacokinetics of quetiapine and two metabolites in human plasma using reversed-phase HPLC with ultraviolet and electrochemical detection. J Pharm Biomed Anal. 1999 Jun;20(1-2):271-82. doi: 10.1016/s0731-7085(99)00036-9.

Results Reference

background

PubMed Identifier

16267634

Citation

Riedel M, Muller N, Strassnig M, Spellmann I, Engel RR, Musil R, Dehning S, Douhet A, Schwarz MJ, Moller HJ. Quetiapine has equivalent efficacy and superior tolerability to risperidone in the treatment of schizophrenia with predominantly negative symptoms. Eur Arch Psychiatry Clin Neurosci. 2005 Dec;255(6):432-7. doi: 10.1007/s00406-005-0622-6. Epub 2005 Nov 4.

Results Reference

background

PubMed Identifier

15383183

Citation

Buckley PF. Efficacy of quetiapine for the treatment of schizophrenia: a combined analysis of three placebo-controlled trials. Curr Med Res Opin. 2004 Sep;20(9):1357-63. doi: 10.1185/030079904125004510.

Results Reference

background

PubMed Identifier

16831113

Citation

Miodownik C, Lerner V. Quetiapine: efficacy, tolerability and safety in schizophrenia. Expert Rev Neurother. 2006 Jul;6(7):983-92. doi: 10.1586/14737175.6.7.983.

Results Reference

result

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A Study to Evaluate the Efficacy and Safety of Seroquel in Chinese Han Patients With Schizophrenia

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