Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia
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ClinicalTrials.gov Identifier: NCT00202007 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: September 20, 2005
|
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | February 2005 |
Study Completion Date : | July 2005 |

- Deduction rate of PANSS total
- PANSS positive
- PANSS negative
- CGI
- CGI improvement

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202007
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 |
Principal Investigator: | Liang Shu, Professor | Institute of Mental Health, Peking University |
ClinicalTrials.gov Identifier: | NCT00202007 History of Changes |
Other Study ID Numbers: |
OBRI0002 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | September 20, 2005 |
Last Verified: | September 2005 |
Keywords provided by Otsuka Beijing Research Institute:
Aripiprazole Schizophrenia Clinical trial Risperidone |
Additional relevant MeSH terms:
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Risperidone Aripiprazole Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents |