BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
NCT00584961
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
- Patients or their legal representatives have provided informed consent
- Patients are unable to complete or to understand health questionnaires in Spanish
language
- Patients enrolled in clinical trials or other studies
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Descriptive Information | ||||
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Brief Title | BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder | |||
Official Title | BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder | |||
Brief 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. 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 Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Community sample. Patients >17 years older with diagnosis of Bipolar Disorder (DSM-IV TR) | |||
Condition | Bipolar Disorder | |||
Intervention | Other: non-interventional
non-interventional | |||
Study Groups/Cohorts | 600 patients
Patients with diagnosis of Bipolar Disorder (DSM-IV TR) Intervention: Other: non-interventional | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 553 | |||
Original Estimated Enrollment | 600 | |||
Actual Study Completion Date | February 2009 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00584961 | |||
Other Study ID Numbers | A1281161 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2021 |