BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00584961
First received: December 21, 2007
Last updated: February 9, 2010
Last verified: February 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bipolar Disorder |
Other: non-interventional |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Clinical Evolution of the Disease [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Cardiovascular Risk [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Current pattern of treatment in Bipolar Disorder [ Time Frame: 12 month ] [ Designated as safety issue: No ]
- Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Patient functional impairment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Patient quality of life [ Time Frame: 12 month ] [ Designated as safety issue: No ]
| Enrollment: | 553 |
| Study Start Date: | May 2007 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
600 patients
Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
|
Other: non-interventional
non-interventional
|
Detailed Description:
Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Community sample. Patients >17 years older with diagnosis of Bipolar Disorder (DSM-IV TR)
Criteria
Inclusion Criteria:
- Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
- Patients or their legal representatives have provided informed consent
Exclusion Criteria:
- Patients are unable to complete or to understand health questionnaires in Spanish language
- Patients enrolled in clinical trials or other studies
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00584961 History of Changes |
| Other Study ID Numbers: | A1281161 |
| Study First Received: | December 21, 2007 |
| Last Updated: | February 9, 2010 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Pfizer:
|
Metabolic Syndrome, Bipolar Disorder and Cardiovascular Risk Factors |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013