Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight (CRESSOB)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 430
- Primary Endpoint
- Evolution of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
To analyse the progress of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months.
To analyse the perceived health status and the level of functioning and disability of patients with schizophrenia and overweight and their progress at 3, 6 and 12 months.
To assess the progress of the symptoms of the disease at 6 and 12 months.
Detailed Description
Consecutive patient sampling. Any investigational site four consecutive patients with diagnosis of Schizophrenia (DSM-IV TR) and Overweight (BMI more or equal to 25 Kg/m2)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR)
- •Patients with BMI (body mass index) more or equal to 25 Kg/m2
- •Patients or their legal representative have provided written informed consent
Exclusion Criteria
- •Patients are unable to complete or to understand health questionnaires in Spanish language
- •Patients are currently enrolled on clinical trials or other investigational studies
Outcomes
Primary Outcomes
Evolution of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months.
Time Frame: 12 months
Secondary Outcomes
- To assess the progress of the symptoms and clinical evolution of the disease(12 months)
- Patient Functional Impairment(12 months)
- Current Pattern of Treatment in this Population(12 months)
- Cardiovascular Risk(12 months)
- Patient Quality of Life(12 months)