Status:
COMPLETED
Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia
Lead Sponsor:
Otsuka Beijing Research Institute
Collaborating Sponsors:
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 unde...
Eligibility Criteria
Inclusion
- 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
- 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
- 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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Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00202007
Start Date
February 1 2005
End Date
July 1 2005
Last Update
November 1 2023
Active Locations (6)
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1
Guangzhou Brain Hospital
Guangzhou, Guangdong, China
2
Psychiatry Dept. People's Hospital, Wuhan University
Wuhan, Hubei, China
3
Mental Health Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
4
Anding Hosp. Capital University of Medical Science
Beijing, China