Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Enrollment :	240 participants
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 :	February 2005
Study Completion Date :	July 2005

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Deduction rate of PANSS total

Secondary Outcome Measures :

1. PANSS positive
2. PANSS negative
3. CGI
4. CGI improvement

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inclusion criteria for screening

1. Schizophrenia or Acute schizophrenia-like psychotic disorder(ICD 10)
2. PANSS total of no less than 60
3. Age: 18-65; male or female
4. 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

1. Tendency or history of suicide
2. Patients with extreme agitation, violent attacking behavior towards people and those who can hardly comply with treatment
3. Diagnosis of other mental diseases besides Schizophrenia
4. 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
5. Patients who take Fluoxetine in the past 1-month before screening
6. Patients who had participated any other clinical trial in the past 1-month before screening
7. History of alcohol or drug abuse or dependence
8. Pregnancy or breast-feeding
9. Patients who have had gastrointestinal operations that could affect drug absorption.
10. Allergy to Risperidone or Aripiprazole or hypersensitiveness to any drug
11. Patients who discontinued long-acting antipsychotics less than one treatment cycle before screening
12. 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
13. 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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Otsuka Beijing Research Institute

Zhejiang Otsuka Pharmaceutical Co., Ltd.

Investigators

Principal Investigator:	Liang Shu, Professor	Institute of Mental Health, Peking University

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00202007 History of Changes
Other Study ID Numbers:	OBRI0002
First Posted:	September 20, 2005
Last Update Posted:	September 20, 2005
Last Verified:	September 2005

Keywords provided by Otsuka Beijing Research Institute:

Aripiprazole; Schizophrenia; Clinical trial; Risperidone

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Risperidone; Aripiprazole; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents	Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents