SchizophreniaNCT00216723
Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder
An observational study of Schizophrenia and Bipolar Disorder, run by Korea Otsuka Pharmaceutical Co., Ltd. at 2 sites in South Korea.
Trial summary
This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- Aripiprazole
- How many people
- 3,000 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2004to Dec 2009
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according to DSM-IV criteria * Age: more than 18 years of age
Who may be able to join
- Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according to DSM-IV criteria
- Age: more than 18 years of age
Who cannot join
- Unqualified patients judged by study investigator(s)
Trial locations and contacts
2 sites in 1 country.
About this study
This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder.
Read the detailed description
This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder.
Qualified schizophrenia patients will be enrolled to an 12-week treatment phase of Aripiprazole by physician's assessment.
Qualified bipolar disorder patients will be enrolled to an 8-week treatment phase of Aripiprazole by physician's assessment.
This study will be continued for 6 years. The final report of Aripiprazole PMS will be submitted to KFDA on December 28, 2009.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- Aripiprazole
- Keywords
- Aripiprazole, Schizophrenia, Bipolar Disorder
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
The recommended starting and target dose for Abilify is 10 or 15mg/day administered on a once-a-day schedule without regard to meals.
(Administer 10 to 30 mg/day according to the patient's condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2004
- Study completionDec 2009
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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jieun Kwon, Study director, Korea Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216723
- Sponsor's protocol ID
- Korea Abilify PMS
- Status last verified
- Oct 2013
- First submitted
- 14 Sep 2005
- Last updated
- 23 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00216723
- Acronym / sponsor ID
- Korea Abilify PMS
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- Aripiprazole, Schizophrenia, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Dec 2009 (actual)
- First posted
- 22 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 is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder.
Detailed description
This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder.
Qualified schizophrenia patients will be enrolled to an 12-week treatment phase of Aripiprazole by physician's assessment.
Qualified bipolar disorder patients will be enrolled to an 8-week treatment phase of Aripiprazole by physician's assessment.
This study will be continued for 6 years. The final report of Aripiprazole PMS will be submitted to KFDA on December 28, 2009.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according to DSM-IV criteria * Age: more than 18 years of age
Key inclusion criteria (2 listed)
- Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according to DSM-IV criteria
- Age: more than 18 years of age
Key exclusion criteria (1 listed)
- Unqualified patients judged by study investigator(s)
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 |
|---|---|---|
| AripiprazoleThe recommended starting and target dose for Abilify is 10 or 15mg/day administered on a once-a-day schedule without regard to meals. (Administer 10 to 30 mg/day according to the patient's condition) | Drug | – |
Primary outcome
Not reported in the source record.
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 23 Oct 2013.
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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.
Jieun Kwon study director
Korea Otsuka Pharmaceutical Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar Disorder, run by Korea Otsuka Pharmaceutical Co., Ltd. at 2 sites 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 2 inclusion and 1 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 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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.
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 23 Oct 2013.