Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

NCT ID: NCT00202007

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2005-07-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Aripiprazole tablet, 5-30mg/day, oral, 6 weeks

Intervention Type: DRUG

Risperidone tablet, 1-6mg/day, oral, 6 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Otsuka Beijing Research Institute

INDUSTRY

Sponsor Role: lead

Principal Investigators

Liang Shu, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Mental Health, Peking University

Locations

Guangzhou Brain Hospital

Guangzhou, Guangdong, China

Psychiatry Dept. People's Hospital, Wuhan University

Wuhan, Hubei, China

Mental Health Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Anding Hosp. Capital University of Medical Science

Beijing, , China

Institute of Mental Health, Peking University

Beijing, , China

Shanghai Mental Health Center

Shanghai, , China

Countries

China

Other Identifiers

OBRI0002

Identifier Type: -

Identifier Source: org_study_id