Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

Sponsor

Otsuka Beijing Research Institute (Industry)

Overall Status

Completed

CT.gov ID

NCT00202007

Collaborator

Zhejiang Otsuka Pharmaceutical Co., Ltd. (Industry)

240

Enrollment

Locations

4.9

Duration (Months)

Patients Per Site

8.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Aripiprazole tablet, 5-30mg/day, oral, 6 weeks Drug: Risperidone tablet, 1-6mg/day, oral, 6 weeks	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2005

Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

Deduction rate of PANSS total []

Secondary Outcome Measures

PANSS positive []
PANSS negative []
CGI []
CGI improvement []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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
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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Guangzhou Brain Hospital	Guangzhou	Guangdong	China
2	Psychiatry Dept. People's Hospital, Wuhan University	Wuhan	Hubei	China
3	Mental Health Hospital, Nanjing Medical University	Nanjing	JIangxu	China
4	Anding Hosp. Capital University of Medical Science	Beijing		China
5	Institute of Mental Health, Peking University	Beijing		China
6	Shanghai Mental Health Center	Shanghai		China