Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aripiprazole tablet, 5-30mg/day, oral, 6 weeks; Drug: Risperidone tablet, 1-6mg/day, oral, 6 weeks

• Study Type: Interventional
• Enrollment: 240
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Deduction rate of PANSS total

Secondary Outcome Measures

Outcome Measure
CGI
PANSS positive
PANSS negative
CGI improvement

Collaborators and Investigators

• Sponsor: Otsuka Beijing Research Institute
• Collaborators: Zhejiang Otsuka Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Liang Shu, Professor, Institute of Mental Health, Peking University

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Study Completion: July 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimated): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: Schizophrenia; Aripiprazole; Risperidone; Clinical trial
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole; Risperidone
• Other Study ID Numbers: OBRI0002