Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00202007
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Beijing Research Institute

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. Deduction rate of PANSS total

Secondary Outcome Measures :
  1. PANSS positive
  2. PANSS negative
  3. CGI
  4. CGI improvement

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00202007

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
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.
Principal Investigator: Liang Shu, Professor Institute of Mental Health, Peking University Identifier: NCT00202007     History of Changes
Other Study ID Numbers: OBRI0002
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: September 2005

Keywords provided by Otsuka Beijing Research Institute:
Clinical trial

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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