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Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Aripiprazole tablet, 5-30mg/day, oral, 6 weeks
Risperidone tablet, 1-6mg/day, oral, 6 weeks
Sponsored by
Otsuka Beijing Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Aripiprazole, Schizophrenia, Clinical trial, Risperidone

Eligibility Criteria

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

Inclusion Criteria: Inclusion criteria for screening Schizophrenia or Acute schizophrenia-like psychotic disorder(ICD 10) PANSS total of no less than 60 Age: 18-65; male or female Informed consent from the legal guardians of the patients Inclusion criteria after washout 1.PANSS total of no less than 60 2.3-7days washout with placebo is required after discontinuation of other oral antipsychotics; No washout is needed for patients who had never taken any antipsychotics before; In cases that patients's condition is deemed clinically deteriorating and immediate treatment is needed, patients with less than 3 days' placebo washout could be randomized after notifying the sponsor 3.No serious function impairment in heart, liver or kidney. - Exclusion Criteria: For screening Tendency or history of suicide Patients with extreme agitation, violent attacking behavior towards people and those who can hardly comply with treatment Diagnosis of other mental diseases besides Schizophrenia Diabetes or other serious unstable diseases or the following neurological diseases, migraine, epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke and TIA etc Patients who take Fluoxetine in the past 1-month before screening Patients who had participated any other clinical trial in the past 1-month before screening History of alcohol or drug abuse or dependence Pregnancy or breast-feeding Patients who have had gastrointestinal operations that could affect drug absorption. Allergy to Risperidone or Aripiprazole or hypersensitiveness to any drug Patients who discontinued long-acting antipsychotics less than one treatment cycle before screening Refractory schizophrenia patients who did not respond to treatments of two different type antipsychotics with adequate dose and course, or patients who did not respond to Clozapine Patients who had Electroconvulsive Therapy (ECT) in the past 6 months After washout 1. Diagnosis of other mental diseases besides schizophrenia during the washout period 2. Significant abnormal ECG or laboratory examination results (ALT,AST>1.5 times of higher limit of normal range), not suitable to be enrolled based on the investigator's discretion. -

Sites / Locations

  • Guangzhou Brain Hospital
  • Psychiatry Dept. People's Hospital, Wuhan University
  • Mental Health Hospital, Nanjing Medical University
  • Anding Hosp. Capital University of Medical Science
  • Institute of Mental Health, Peking University
  • Shanghai Mental Health Center

Outcomes

Primary Outcome Measures

Deduction rate of PANSS total

Secondary Outcome Measures

PANSS positive
PANSS negative
CGI
CGI improvement

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
Otsuka Beijing Research Institute
Collaborators
Zhejiang Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00202007
Brief Title
Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia
Official Title
A Multi-Center, Randomized, Double-Blind Study, Comparing With Risperidone, to Evaluate the Efficacy and Safety of Aripiprazole in the Treatment of Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Beijing Research Institute
Collaborators
Zhejiang Otsuka Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
This study design is subject to relevant SFDA regulations about clinical trials. Patients will be screened for inclusion into the study at the initial visit(240 patients to be recruited) and then undergo a minimum of 3-7 day's placebo washout period(placebo wash out is to eliminate the effect of prior antipsychotic medication with tablets without any active ingredients)(patients without prior antipsychotic medication are exempt from the washout phase). After screening and washout period, eligible patients will be randomly assigned to the two treatment group, Aripiprazole or Risperidone, for 6 week's treatment. Patients will be hospitalized for the entire duration of the study. Patients' condition will be assessed weekly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Aripiprazole, Schizophrenia, Clinical trial, Risperidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aripiprazole tablet, 5-30mg/day, oral, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Risperidone tablet, 1-6mg/day, oral, 6 weeks
Primary Outcome Measure Information:
Title
Deduction rate of PANSS total
Secondary Outcome Measure Information:
Title
PANSS positive
Title
PANSS negative
Title
CGI
Title
CGI improvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for screening Schizophrenia or Acute schizophrenia-like psychotic disorder(ICD 10) PANSS total of no less than 60 Age: 18-65; male or female Informed consent from the legal guardians of the patients Inclusion criteria after washout 1.PANSS total of no less than 60 2.3-7days washout with placebo is required after discontinuation of other oral antipsychotics; No washout is needed for patients who had never taken any antipsychotics before; In cases that patients's condition is deemed clinically deteriorating and immediate treatment is needed, patients with less than 3 days' placebo washout could be randomized after notifying the sponsor 3.No serious function impairment in heart, liver or kidney. - Exclusion Criteria: For screening Tendency or history of suicide Patients with extreme agitation, violent attacking behavior towards people and those who can hardly comply with treatment Diagnosis of other mental diseases besides Schizophrenia Diabetes or other serious unstable diseases or the following neurological diseases, migraine, epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke and TIA etc Patients who take Fluoxetine in the past 1-month before screening Patients who had participated any other clinical trial in the past 1-month before screening History of alcohol or drug abuse or dependence Pregnancy or breast-feeding Patients who have had gastrointestinal operations that could affect drug absorption. Allergy to Risperidone or Aripiprazole or hypersensitiveness to any drug Patients who discontinued long-acting antipsychotics less than one treatment cycle before screening Refractory schizophrenia patients who did not respond to treatments of two different type antipsychotics with adequate dose and course, or patients who did not respond to Clozapine Patients who had Electroconvulsive Therapy (ECT) in the past 6 months After washout 1. Diagnosis of other mental diseases besides schizophrenia during the washout period 2. Significant abnormal ECG or laboratory examination results (ALT,AST>1.5 times of higher limit of normal range), not suitable to be enrolled based on the investigator's discretion. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Shu, Professor
Organizational Affiliation
Institute of Mental Health, Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Brain Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Psychiatry Dept. People's Hospital, Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Mental Health Hospital, Nanjing Medical University
City
Nanjing
State/Province
JIangxu
Country
China
Facility Name
Anding Hosp. Capital University of Medical Science
City
Beijing
Country
China
Facility Name
Institute of Mental Health, Peking University
City
Beijing
Country
China
Facility Name
Shanghai Mental Health Center
City
Shanghai
Country
China

12. IPD Sharing Statement

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Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

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