SchizophreniaPhase 4NCT00304616
SWitching to Abilify Trial (SWAT)
A Phase 4 study testing Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone in people with Schizophrenia, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration 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, Solian, Olanzapine, Seroquel, Risperidone
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2004to Oct 2007
- Phase
- Phase 4
- 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
- Signed written informed consent
- Men and women, ages 18 to 65. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
- Patients who have not been hospitalized during last three months
- Patients who have kept clinically stable dosage during last one month
- Patients with a diagnosis of schizophrenia and schizoaffective disorder as defined by DSM-IV criteria
- Patients whose symptoms are not optimally controlled or whose antipsychotic medication is not well-tolerated, which in the clinical judgment of the treating psychiatrist require a change of treatment.
- Patients who have received antipsychotics in the past must have shown a response to a neuroleptic medication other than clozapine.
Who cannot join
- Patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- Women who are pregnant or breastfeeding
- Patients who are at risk for committing suicide: either having active suicidal ideation considered clinically significant or recently attempted suicide
- Patients with a diagnosis of bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
- Patients who have met DSM-IV criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
- Patients considered treatment-resistant to antipsychotic medication (patients need to have shown a previous response to a antipsychotic medication other than clozapine) and patients with a significant history of intolerance to multiple antipsychotic treatments
Show all 12Show fewer
- Treatment with a long-acting antipsychotic (i.e., haloperidol decanoate or fluphenazine decanoate) in which the last dose was within 3 weeks of randomization.
- Patients with a history of neuroleptic malignant syndrome
- Patients with epilepsy, a history of seizures (except for a single childhood febrile seizure), or a history of an abnormal EEG, severe head trauma, or stroke or who have a history or evidence of other medical conditions (e.g., congestive heart failure) that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial
- Patients who would be likely to require prohibited concomitant therapy during the trial
- Patients who have previously enrolled in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month
- Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Open, Treatment-switching Study From Orally Administered Antipsychotic Monotherapy in the Treatment of Chronic Schizophrenic and Schizoaffective Patients
To evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration
Read the detailed description
This trial was designed to evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration to schizophrenic outpatients who maintain stable (no change with dosage, usage, route of the most recent antipsychotic drugs) symptoms and discontinued previous antipsychotic drugs.
Aripiprazole (10~30 mg/day) will be orally administered for 12 weeks followed by an extension phase for a maximum of an additional 14 weeks (total of 26 weeks).
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone
- Keywords
- Schizophrenia, Aripiprazole
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole, Solian, Olanzapine, Seroquel, RisperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)
Secondary outcomes (6)
Changes in PANSS total & PANSS subscore & depression subscore originated from PANSS (at week 4, 8 & every 4 weeks until week 26
IAQ (at week 8)
POM (at week 1, 2, 4, 8)
GAF (at week 8 & end of study)
CGI-S (at week 1, 3, 4, 8 & every 4 weeks until week 26)
AEs, Vital Signs, Weight gain, Prolactin increase, extrapyramidal syndrome, sleep disturbance, Laboratory tests (at week 1, 2, 4, 8 & every 4 weeks until week 26).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startOct 2004
- Primary completionJun 2006
- Study completionOct 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Chang-Yoon Kim, Prof., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304616
- Sponsor's protocol ID
- KOP-010402
- Status last verified
- Dec 2009
- First submitted
- 17 Mar 2006
- Last updated
- 17 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open, Treatment-switching Study From Orally Administered Antipsychotic Monotherapy in the Treatment of Chronic Schizophrenic and Schizoaffective Patients
- ClinicalTrials.gov ID
- NCT00304616
- Acronym / sponsor ID
- KOP-010402
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Aripiprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 20 Mar 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 tolerance of an 12 and 26-week aripiprazole administration
Detailed description
This trial was designed to evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration to schizophrenic outpatients who maintain stable (no change with dosage, usage, route of the most recent antipsychotic drugs) symptoms and discontinued previous antipsychotic drugs.
Aripiprazole (10~30 mg/day) will be orally administered for 12 weeks followed by an extension phase for a maximum of an additional 14 weeks (total of 26 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent
- Men and women, ages 18 to 65. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
- Patients who have not been hospitalized during last three months
- Patients who have kept clinically stable dosage during last one month
- Patients with a diagnosis of schizophrenia and schizoaffective disorder as defined by DSM-IV criteria
Key exclusion criteria (12 listed)
- Patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- Women who are pregnant or breastfeeding
- Patients who are at risk for committing suicide: either having active suicidal ideation considered clinically significant or recently attempted suicide
- Patients with a diagnosis of bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
- Patients who have met DSM-IV criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
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, Solian, Olanzapine, Seroquel, Risperidone | Drug | – |
Primary outcome
CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)
6 secondary outcomes
Changes in PANSS total & PANSS subscore & depression subscore originated from PANSS (at week 4, 8 & every 4 weeks until week 26
IAQ (at week 8)
POM (at week 1, 2, 4, 8)
GAF (at week 8 & end of study)
CGI-S (at week 1, 3, 4, 8 & every 4 weeks until week 26)
AEs, Vital Signs, Weight gain, Prolactin increase, extrapyramidal syndrome, sleep disturbance, Laboratory tests (at week 1, 2, 4, 8 & every 4 weeks until week 26).
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 17 Dec 2009.
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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.
Chang-Yoon Kim, Prof. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone in people with Schizophrenia, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 7 inclusion and 12 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 17 Dec 2009. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26). 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 17 Dec 2009; AzTrials last refreshed its copy on 30 Oct 2026.