Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Seroquel in Chinese Han Patients With Schizophrenia
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 scor...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00817648
Start Date
December 1 2008
End Date
May 1 2010
Last Update
June 15 2010
Active Locations (4)
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1
Mental Health Center of Luwan District
Shanghai, Shanghai Municipality, China, 200020
2
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
3
Branch Hospital of Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 201108
4
Huzhou Third People Hospital
Huzhou, Zhejiang, China, 313000