Bipolar Disorder
Conditions
Keywords
Metabolic Syndrome, Bipolar Disorder and Cardiovascular Risk Factors
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
Interventions
OTHERnon-interventional
non-interventional
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides) | 12 months |
| Clinical Evolution of the Disease | 12 months |
| Cardiovascular Risk | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Current pattern of treatment in Bipolar Disorder | 12 month |
| Patient quality of life | 12 month |
| Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder | 1 day |
| Patient functional impairment | 12 months |
Outcome results
None listed