Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia - Full Text View

Purpose

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	Intervention	Phase
Schizophrenia	Drug: Aripiprazole tablet, 5-30mg/day, oral, 6 weeks Drug: Risperidone tablet, 1-6mg/day, oral, 6 weeks	Phase II

MedlinePlus related topics:

Mental Health Schizophrenia

Drug Information available for:

Risperidone Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Otsuka Beijing Research Institute:

Primary Outcome Measures:

Deduction rate of PANSS total

Secondary Outcome Measures:

PANSS positive
PANSS negative
CGI
CGI improvement

Estimated Enrollment:	240
Study Start Date:	February 2005
Estimated Study Completion Date:	July 2005

Eligibility

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

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.

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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.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202007

Locations


China
	Institute of Mental Health, Peking University
	Beijing, China
	Anding Hosp. Capital University of Medical Science
	Beijing, China
	Shanghai Mental Health Center
	Shanghai, China

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

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

Study ID Numbers:	OBRI0002
First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00202007
Health Authority:	China: State Food and Drug Administration

Keywords provided by Otsuka Beijing Research Institute:

Aripiprazole

Schizophrenia

Clinical trial

Risperidone

Study placed in the following topic categories:

Schizophrenia

Dopamine

Mental Disorders

Risperidone

Psychotic Disorders

Aripiprazole

Serotonin

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Dopamine Antagonists

Antipsychotic Agents

Pharmacologic Actions

Serotonin Antagonists

Serotonin Agents

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 22, 2008

Sponsors and Collaborators:	Otsuka Beijing Research Institute Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:	NCT00202007