- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00202007
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
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
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
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
- 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.
-
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
Collaborators
Investigators
- Principal Investigator: Liang Shu, Professor, Institute of Mental Health, Peking University
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on Aripiprazole tablet, 5-30mg/day, oral, 6 weeks
-
Otsuka Pharmaceutical Co., Ltd.CompletedSchizophreniaJapan
-
Chulalongkorn UniversityRecruiting
-
Children's Hospital of Fudan UniversityWithdrawn
-
Ain Shams UniversityCompleted
-
Ukrainian Medical Stomatological AcademyCompletedAdverse Effect | Atherosclerosis, Coronary | Insulin Resistance SyndromeUkraine
-
National Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States