Bipolar DisorderBIMETNCT00584961
BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
An observational study of Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder. To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- non-interventional
- Type of treatment
- Injection or infusion
- How many people
- 553 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample. Patients >17 years older with diagnosis of Bipolar Disorder (DSM-IV TR)
Who may be able to join
- Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
- Patients or their legal representatives have provided informed consent
Who cannot join
- Patients are unable to complete or to understand health questionnaires in Spanish language
- Patients enrolled in clinical trials or other studies
About this study
To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder.
To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk.
To analyse the health status, quality of life and functioning/disability of patients.
Read the detailed description
Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study
- Conditions
- Bipolar Disorder
- Being tested
- non-interventional
- Keywords
- Metabolic Syndrome, Bipolar Disorder and Cardiovascular Risk Factors
- Medical subject headings
- Bipolar Disorder, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionalOther
non-interventional
| Study group | Role | What they receive |
|---|---|---|
| 600 patients | Patients with diagnosis of Bipolar Disorder (DSM-IV TR) Receives: Other: non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides)
Measured: 12 months
Clinical Evolution of the Disease
Measured: 12 months
Cardiovascular Risk
Measured: 12 months
Secondary outcomes (4)
Current pattern of treatment in Bipolar Disorder
Measured: 12 month
Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder
Measured: 1 day
Patient functional impairment
Measured: 12 months
Patient quality of life
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startMay 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584961
- Sponsor's protocol ID
- A1281161
- Acronym
- BIMET
- Status last verified
- Feb 2021
- First submitted
- 21 Dec 2007
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00584961
- Acronym / sponsor ID
- BIMET / A1281161
- Conditions
- Bipolar Disorder
- Keywords
- Metabolic Syndrome, Bipolar Disorder and Cardiovascular Risk Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 Jan 2008 (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 assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder.
To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk.
To analyse the health status, quality of life and functioning/disability of patients.
Detailed description
Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 600 patients | – | Other: non-interventionalPatients with diagnosis of Bipolar Disorder (DSM-IV TR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample. Patients >17 years older with diagnosis of Bipolar Disorder (DSM-IV TR)
Key inclusion criteria (2 listed)
- Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
- Patients or their legal representatives have provided informed consent
Key exclusion criteria (2 listed)
- Patients are unable to complete or to understand health questionnaires in Spanish language
- Patients enrolled in clinical trials or other studies
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 |
|---|---|---|
| non-interventionalnon-interventional | Other | 600 patients |
Primary outcome
Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides)
Time frame: 12 months
Clinical Evolution of the Disease
Time frame: 12 months
Cardiovascular Risk
Time frame: 12 months
4 secondary outcomes
Current pattern of treatment in Bipolar Disorder
Time frame: 12 month
Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder
Time frame: 1 day
Patient functional impairment
Time frame: 12 months
Patient quality of life
Time frame: 12 month
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 21 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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 2 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 21 Feb 2021.