Bipolar DisordersPhase 4NCT00845988
Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders
A Phase 4 study testing aripiprazole in people with Bipolar Disorders and Metabolic Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorders, Metabolic Complication
- What is being tested?
- aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Mar 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria
- age between 18 and 65
- Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3
- patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain)
Who cannot join
- diagnosis of eating disorder, substance abuse, and psychotic disorder
- history of neurological and medical illness
- pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders Having Drug-induced Weight Gain
The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.
Read the detailed description
- reduced treatment adherence due to metabolic side effects
- suggested advantages of aripiprazole in metabolic profile over other antipsychotics or mood stabilizers
- randomized trial of switch from previous drugs to aripiprazole
- Conditions
- Bipolar Disorders, Metabolic Complication
- Being tested
- aripiprazole
- Keywords
- Bipolar disorder, metabolic complication, Aripiprazole, Weight gain, Clinical Trial, Antipsychotic, Metabolic syndrome, Psychopharmacology, Open Label
- Medical subject headings
- Bipolar Disorder, Weight Gain, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks
| Study group | Role | What they receive |
|---|---|---|
| treatment as usual | Active comparator | patients showing weight gain while receiving treatment with risperidone, olanzapine, quetiapine, or clozapine Receives: Drug: aripiprazole |
| switch to aripiprazole | Experimental | aripiprazole Receives: Drug: aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K
Measured: 0, 4, 8, 12, 18, 26 week
Secondary outcomes (1)
ECG prolactin SAS BAS UKU-SERS-Pat-Korean version
Measured: 0, 4, 8, 12, 18, 26 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisordersStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Kyooseob Ha, Seoul National University Bundang Hospital
- Investigators
- Kyooseob Ha, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845988
- Sponsor's protocol ID
- 06-2008-104
- Status last verified
- Dec 2013
- First submitted
- 14 Feb 2009
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders Having Drug-induced Weight Gain
- ClinicalTrials.gov ID
- NCT00845988
- Acronym / sponsor ID
- 06-2008-104
- Conditions
- Bipolar Disorders, Metabolic Complication
- Keywords
- Bipolar disorder, metabolic complication, Aripiprazole, Weight gain, Clinical Trial, Antipsychotic, Metabolic syndrome, Psychopharmacology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- Dec 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Feb 2009 (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.
The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.
Detailed description
- reduced treatment adherence due to metabolic side effects
- suggested advantages of aripiprazole in metabolic profile over other antipsychotics or mood stabilizers
- randomized trial of switch from previous drugs to aripiprazole
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment as usual | Active comparator | Drug: aripiprazolepatients showing weight gain while receiving treatment with risperidone, olanzapine, quetiapine, or clozapine |
| switch to aripiprazole | Experimental | Drug: aripiprazolearipiprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria
- age between 18 and 65
- Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3
- patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain)
Key exclusion criteria (3 listed)
- diagnosis of eating disorder, substance abuse, and psychotic disorder
- history of neurological and medical illness
- pregnant or breast feeding women
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 |
|---|---|---|
| aripiprazoledosage form : po recommended dosage : more than 10mg/day duration : 28 weeks | Drug | switch to aripiprazole, treatment as usual |
Primary outcome
Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K
Time frame: 0, 4, 8, 12, 18, 26 week
1 secondary outcome
ECG prolactin SAS BAS UKU-SERS-Pat-Korean version
Time frame: 0, 4, 8, 12, 18, 26 week
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 5 Dec 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.
Kyooseob Ha, MD, PhD principal investigator
Seoul National University Bundang Hospital
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 in people with Bipolar Disorders and Metabolic Complication, run by Seoul National University Hospital 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 4 inclusion and 3 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 5 Dec 2013. 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?
Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K (time frame: 0, 4, 8, 12, 18, 26 week). 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 5 Dec 2013.