SchizophreniaPhase 3NCT00283179
Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia
A Phase 3 study testing Aripiprazole and Risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Taiwan Otsuka Pharm. Co., Ltd at 1 site in Taiwan.
Trial summary
To evaluate the efficacy, safety and tolerability of aripiprazole in the treatment of acutely relapsed patients with diagnoses of schizophrenia or schizoaffective disorder with risperidone as an active control. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Aripiprazole and Risperidone
- How many people
- 83 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2004to Dec 2004
- Phase
- Phase 3
- 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
- Diagnosis: Schizophrenia or schizoaffective disorder, in an acute relapse.
- Duration of present episode/relapse: Randomization to this study occurred no more than four weeks following the day of initiation of any treatment for the last episode/relapse.
- Age: 18 to 65 years.
- Gender: Males and females (females of childbearing potential had a negative serum pregnancy test from screening visit, used acceptable contraception, and were not pregnant or lactating).
- Response to previous antipsychotic agents: Patients had responded to previous antipsychotic medication
- Current antipsychotic treatment: Prior to beginning the placebo-washout, patients had not been treated with a long-acting antipsychotic within the time required for one cycle of treatment with that long-acting antipsychotic, plus one week. Patients who had been treated with a long-acting antipsychotic within less than this time period might be enrolled in the study, providing they were judged by the investigator to be clearly clinically deteriorating.
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- Positive and Negative Syndrome Scale scores: Patients had a total PANSS score of at least 60. In addition, patients had a score of at least 4 on any two of the four PANSS items that constitute a psychotic items subscale.
- Compliance with the protocol: Patients were rated reliably on the battery of psychiatric and movement rating scales required by the protocol.
- Informed Consent: Patients eligible to enter the study signed an informed consent form prior to the initiation of any study procedures.
Who cannot join
- Patients who, in the opinion of the investigator, had serious suicidal ideation or patients who were liable to serious suicide attempt, by clinical judgment.
- Patients presented with a first episode of schizophrenia or schizoaffective disorder
- Patients who had any of the following neurological diagnoses, whether under treatment or not, whether stable or not: migraine, epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis, residual of stroke, transient cerebral ischemic attacks, 'cerebral palsy' or any condition that required intermittent or maintenance treatment, or which was manifested by any abnormality on neurological examination.
- Patients who continued to take, or who potentially needed to take, during the double-blind portion of this study, any of the following concomitant medications, which could cause unwanted drug-to-drug interactions or which could confound the analysis of antipsychotic effectiveness of the randomly assigned study drug: carbamazepine, valproic acid or sodium valproate or divalproate sodium, lithium carbonate or lithium citrate.
- Patients who failed to withdraw from fluoxetine treatment at least 28 days prior to screening, if on treatment with fluoxetine.
- Patients with any gastrointestinal resection, stomach stapling, or any other condition that may impair the absorption of the study medication.
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- Patients who had positive result in the urine screen for drugs of abuse (except for cannabis or medically-prescribed analgesics or benzodiazepines.)
- Patients who met the DSM-IV criteria for psychoactive substance dependence or patients with a history of substance or alcohol dependence within one month prior to the beginning of the study.
- Patients had any somatic condition whose symptoms or physical signs could be misinterpreted as signs or symptoms of schizophrenia or as adverse effects from antipsychotic medications.
- Patients with any acute or unstable medical condition.
- Patients who had taken an investigational drug within the four weeks, which preceded the start of placebo washout.
- Patients who were treatment-resistant.
- Patients who continued to take, or who potentially needed to take, during this study, any medication or substance that is known to be an inhibitor of the microsomal enzyme CYP2D6, or an inhibitor or a substrate of the microsomal enzyme CYP3A4.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia or Schizoaffective Disorder With Risperidone as an Active Control
To evaluate the efficacy, safety and tolerability of aripiprazole in the treatment of acutely relapsed patients with diagnoses of schizophrenia or schizoaffective disorder with risperidone as an active control.
Read the detailed description
Medical treatment of schizophrenia uses antipsychotic drugs, which ameliorate the acute episodes and probably prevent or decrease the risk of occurrence of new episodes. Most antipsychotics share the ability to block postsynaptic dopaminergic receptors of the D2 subtype.
The typical antipsychotics (such as haloperidol and chlorpromazine) ameliorate acute episodes and possibly prevent or decrease the risk of occurrence of new episodes, but they have minimal effectiveness against negative symptoms, mood symptoms, and cognitive impairment, which often lead to poor social functioning. Its full Dopamine antagonism is often associated with a number of well-recognized debilitating side effects. One example is EPS. A new class of antipsychotics, the atypical agents (such as clozapine, risperidone, olanzapine), became available starting in the late-1980s. Their mode of action affects both the serotonin and dopamine (DA) receptors. They are better tolerated than the typical antipsychotics with regard to EPS, except at higher doses. The improvement in the side effect profile seen with the atypical antipsychotics is accompanied by efficacy against positive symptoms and perhaps some improvement in efficacy against negative symptoms. Although they offer better efficacy and lower rates of EPS compared to typical agents, they are associated with other side effects that may be of clinical concern. For example, olanzapine and clozapine have an increased incidence of weight gain and diabetes mellitus, risperidone is associated with hyperprolactinemia, and ziprasidone is associated with ECG QT interval prolongation. In addition to tolerability issues, a significant proportion of patients still do not adequately respond to these newer agents. A need still exists for efficacious alternatives that demonstrate improved tolerability and side effect profiles so as to enhance treatment compliance and long-term functioning.
Aripiprazole is a novel DA-serotonin stabilizer approved in U.S. for the management of schizophrenia. The unique mode of action of aripiprazole translates into efficacy against psychotic symptoms and a more favorable safety profile than current treatment. Its introduction will clearly provide patients and their families with a much-needed alternative to the antipsychotics currently available.
This study further examined the efficacy and safety of aripiprazole in patients having acute relapse of schizophrenia or schizoaffective disorder in Taiwan. The duration of this study was 4 weeks.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Aripiprazole, Risperidone
- Keywords
- Aripiprazole, Risperidone, Schizophrenia, Schizoaffective disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
RisperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS-total score
Secondary outcomes (1)
PANSS-positive score, PANSS-negative score, CGI-severity score, CGI-improvement score, and safety/tolerability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startMar 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Otsuka Pharm. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tzung-Jeng Hwang, M.D., M.P.H., Principal investigator, National Taiwan University HospitalHung-Yu Chan, M.D., Principal investigator, Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. TaiwanWei-Wen Lin, M.D., Ph.D., Principal investigator, Tri-Service General Hospital (TSGH)Shih-Ku Lin, M.D., Principal investigator, Taipei City Psychiatric CenterTung-Ping T. Su, M.D., Principal investigator, Taipei Veterans General Hospital, TaiwanHai-Gwo Hwu, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283179
- Sponsor's protocol ID
- 31-02-A01
- Status last verified
- Jan 2006
- First submitted
- 26 Jan 2006
- Last updated
- 15 May 2008
- Results posted
- No
Publications
Chan HY, Lin WW, Lin SK, Hwang TJ, Su TP, Chiang SC, Hwu HG. Efficacy and safety of aripiprazole in the acute treatment of schizophrenia in Chinese patients with risperidone as an active control: a randomized trial. J Clin Psychiatry. 2007 Jan;68(1):29-36. doi: 10.4088/jcp.v68n0104.
PubMed 17284127
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia or Schizoaffective Disorder With Risperidone as an Active Control
- ClinicalTrials.gov ID
- NCT00283179
- Acronym / sponsor ID
- 31-02-A01
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Aripiprazole, Risperidone, Schizophrenia, Schizoaffective disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Taiwan Otsuka Pharm. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Dec 2004 (actual)
- First posted
- 27 Jan 2006 (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.
To evaluate the efficacy, safety and tolerability of aripiprazole in the treatment of acutely relapsed patients with diagnoses of schizophrenia or schizoaffective disorder with risperidone as an active control.
Detailed description
Medical treatment of schizophrenia uses antipsychotic drugs, which ameliorate the acute episodes and probably prevent or decrease the risk of occurrence of new episodes. Most antipsychotics share the ability to block postsynaptic dopaminergic receptors of the D2 subtype.
The typical antipsychotics (such as haloperidol and chlorpromazine) ameliorate acute episodes and possibly prevent or decrease the risk of occurrence of new episodes, but they have minimal effectiveness against negative symptoms, mood symptoms, and cognitive impairment, which often lead to poor social functioning. Its full Dopamine antagonism is often associated with a number of well-recognized debilitating side effects. One example is EPS. A new class of antipsychotics, the atypical agents (such as clozapine, risperidone, olanzapine), became available starting in the late-1980s. Their mode of action affects both the serotonin and dopamine (DA) receptors. They are better tolerated than the typical antipsychotics with regard to EPS, except at higher doses. The improvement in the side effect profile seen with the atypical antipsychotics is accompanied by efficacy against positive symptoms and perhaps some improvement in efficacy against negative symptoms. Although they offer better efficacy and lower rates of EPS compared to typical agents, they are associated with other side effects that may be of clinical concern. For example, olanzapine and clozapine have an increased incidence of weight gain and diabetes mellitus, risperidone is associated with hyperprolactinemia, and ziprasidone is associated with ECG QT interval prolongation. In addition to tolerability issues, a significant proportion of patients still do not adequately respond to these newer agents. A need still exists for efficacious alternatives that demonstrate improved tolerability and side effect profiles so as to enhance treatment compliance and long-term functioning.
Aripiprazole is a novel DA-serotonin stabilizer approved in U.S. for the management of schizophrenia. The unique mode of action of aripiprazole translates into efficacy against psychotic symptoms and a more favorable safety profile than current treatment. Its introduction will clearly provide patients and their families with a much-needed alternative to the antipsychotics currently available.
This study further examined the efficacy and safety of aripiprazole in patients having acute relapse of schizophrenia or schizoaffective disorder in Taiwan. The duration of this study was 4 weeks.
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 (9 listed)
- Diagnosis: Schizophrenia or schizoaffective disorder, in an acute relapse.
- Duration of present episode/relapse: Randomization to this study occurred no more than four weeks following the day of initiation of any treatment for the last episode/relapse.
- Age: 18 to 65 years.
- Gender: Males and females (females of childbearing potential had a negative serum pregnancy test from screening visit, used acceptable contraception, and were not pregnant or lactating).
- Response to previous antipsychotic agents: Patients had responded to previous antipsychotic medication
Key exclusion criteria (13 listed)
- Patients who, in the opinion of the investigator, had serious suicidal ideation or patients who were liable to serious suicide attempt, by clinical judgment.
- Patients presented with a first episode of schizophrenia or schizoaffective disorder
- Patients who had any of the following neurological diagnoses, whether under treatment or not, whether stable or not: migraine, epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis, residual of stroke, transient cerebral ischemic attacks, 'cerebral palsy' or any condition that required intermittent or maintenance treatment, or which was manifested by any abnormality on neurological examination.
- Patients who continued to take, or who potentially needed to take, during the double-blind portion of this study, any of the following concomitant medications, which could cause unwanted drug-to-drug interactions or which could confound the analysis of antipsychotic effectiveness of the randomly assigned study drug: carbamazepine, valproic acid or sodium valproate or divalproate sodium, lithium carbonate or lithium citrate.
- Patients who failed to withdraw from fluoxetine treatment at least 28 days prior to screening, if on treatment with fluoxetine.
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 | Drug | – |
| Risperidone | Drug | – |
Primary outcome
PANSS-total score
1 secondary outcome
PANSS-positive score, PANSS-negative score, CGI-severity score, CGI-improvement score, and safety/tolerability.
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 15 May 2008.
- Results publication: PubMed 17284127Chan HY, Lin WW, Lin SK, Hwang TJ, Su TP, Chiang SC, Hwu HG. Efficacy and safety of aripiprazole in the acute treatment of schizophrenia in Chinese patients with risperidone as an active control: a randomized trial. J Clin Psychiatry. 2007 Jan;68(1):29-36. doi: 10.4088/jcp.v68n0104.
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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.
Tzung-Jeng Hwang, M.D., M.P.H. principal investigator
National Taiwan University Hospital
Hung-Yu Chan, M.D. principal investigator
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Wei-Wen Lin, M.D., Ph.D. principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole and Risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Taiwan Otsuka Pharm. Co., Ltd at 1 site in Taiwan.
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 9 inclusion and 13 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 15 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
PANSS-total score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00283179, which also lists 1 linked publication.
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 15 May 2008; AzTrials last refreshed its copy on 8 Nov 2026.