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

Sponsor:	Shanghai Mental Health Center
Information provided by:	Shanghai Mental Health Center
ClinicalTrials.gov Identifier:	NCT00817648

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Quetiapine Drug: risperidone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Mental Health Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by Shanghai Mental Health Center:

Primary Outcome Measures:

the change of PANSS total score [ Time Frame: from the baseline to week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Quetiapine 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.
2: Active Comparator	Drug: risperidone 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817648

Contacts

Contact: Huafang LI, MD,PhD	86-21-64387250 ext 3128	lhlh5@yahoo.com.cn
Contact: Yan LI, MD	86-21-64387250 ext 3122	liyan7721@yeah.net

Locations

China
Shanghai Mental Health Center	Recruiting
Shanghai, China, 200030
Contact: Huafang LI, MD, PhD 86-21-64387250 ext 3128 lhlh5@yahoo.com.cn
Contact: Yan LI, MD 86-21-64387250 ext 3122 liyan7721@yeah.net
Principal Investigator: Huafang LI, MD, PhD
Sub-Investigator: Yan LI, B Med
Sub-Investigator: Huifang WANG, B Med
Sub-Investigator: Feng YAN, B Med
Sub-Investigator: Han CHEN, B Med
Sub-Investigator: Kaimin ZHUO, B Med
Sub-Investigator: Jinyun MA, B Med
Sub-Investigator: Yun XU, B Med
Sub-Investigator: Ting SHEN, B Med
Sub-Investigator: Daihui PENG, MD, PhD
Branch Hospital of Shanghai Mental Health Center	Recruiting
Shanghai, China, 201108
Contact: Yan LIU, MS swo.l@163.com
Principal Investigator: Yan LIU, MS
Sub-Investigator: Hongyu DENG, B Med
Mental Health Center of Luwan District	Recruiting
Shanghai, China, 200020
Contact: Ying YUE, MS 86-21-53010724 yueying68715@yahoo.com.cn
Principal Investigator: Ying YUE, MS
Sub-Investigator: Xiaoyun LENG, B Med
China, Zhejiang
Huzhou Third People Hospital	Recruiting
Huzhou, Zhejiang, China, 313000
Contact: Mincai QIAN, B Med 0572-2214019 qmc@hzsy.com
Principal Investigator: Mincai QIAN, B Med
Sub-Investigator: Jianhong YANG, MS
Sub-Investigator: Lie REN, MS

Sponsors and Collaborators

Shanghai Mental Health Center

Investigators

Principal Investigator:

Huafang LI, MD,PhD

Drug Clinical Trial Office, Shanghai Mental Health Center

More Information

Publications:

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

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.

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.

Riedel M, Müller N, Strassnig M, Spellmann I, Engel RR, Musil R, Dehning S, Douhet A, Schwarz MJ, Möller 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. Epub 2005 Nov 4.

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.

Responsible Party:	Shanghai Mental Health Center ( LI, Huafang )
Study ID Numbers:	D1443L00071, SMHC-098
Study First Received:	January 5, 2009
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00817648 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Shanghai Mental Health Center:

schizophrenia
antipsychotics
quetiapine
risperidone
efficacy
safety

multicenter
rater-blind
randomized
chinese
han

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions

Schizophrenia
Quetiapine
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010