SchizophreniaPhase 2NCT00202007
Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia
A Phase 2 study testing Aripiprazole tablet, 5-30mg/day, oral, 6 weeks and Risperidone tablet, 1-6mg/day, oral, 6 weeks in people with Schizophrenia, run by Otsuka Beijing Research Institute at 6 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole tablet, 5-30mg/day, oral, 6 weeks and Risperidone tablet, 1-6mg/day, oral, 6 weeks
- Type of treatment
- Pill or oral medicine
- How many people
- 240 participants
- Where
- 6 sitesChina
- Study dates
- Feb 2005to Jul 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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
Show all 16Show fewer
- 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.
- -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Anding Hosp. Capital University of Medical Science
Beijing
Institute of Mental Health, Peking University
Beijing
Guangzhou Brain Hospital
Guangzhou, Guangdong
Mental Health Hospital, Nanjing Medical University
Nanjing, Jiangsu
Shanghai Mental Health Center
Shanghai
Psychiatry Dept. People's Hospital, Wuhan University
Wuhan, Hubei
About this study
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
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
- Being tested
- Aripiprazole tablet, 5-30mg/day, oral, 6 weeks, Risperidone tablet, 1-6mg/day, oral, 6 weeks
- Keywords
- Aripiprazole, Schizophrenia, Clinical trial, Risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole tablet, 5-30mg/day, oral, 6 weeksDrug
Risperidone tablet, 1-6mg/day, oral, 6 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Deduction rate of PANSS total
Secondary outcomes (4)
PANSS positive
PANSS negative
CGI
CGI improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Liang Shu, Professor, Principal investigator, Institute of Mental Health, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202007
- Sponsor's protocol ID
- OBRI0002
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 1 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00202007
- Acronym / sponsor ID
- OBRI0002
- Conditions
- Schizophrenia
- Keywords
- Aripiprazole, Schizophrenia, Clinical trial, Risperidone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Otsuka Pharmaceutical Co., Ltd.
- Study start
- Feb 2005
- Study completion
- Jul 2005
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazole tablet, 5-30mg/day, oral, 6 weeks | Drug | – |
| Risperidone tablet, 1-6mg/day, oral, 6 weeks | Drug | – |
Primary outcome
Deduction rate of PANSS total
4 secondary outcomes
PANSS positive
PANSS negative
CGI
CGI improvement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang Shu, Professor principal investigator
Institute of Mental Health, Peking University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aripiprazole tablet, 5-30mg/day, oral, 6 weeks and Risperidone tablet, 1-6mg/day, oral, 6 weeks in people with Schizophrenia, run by Otsuka Beijing Research Institute at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deduction rate of PANSS total. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.