Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:
NCT00202007
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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

  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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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

Keywords provided by Otsuka Beijing Research Institute:
Aripiprazole
Schizophrenia
Clinical trial
Risperidone

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Aripiprazole
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014