BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
NCT00584961
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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 | ||||
|---|---|---|---|---|
| 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 | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2010 | |||