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NCT00584519 Clinical Trial

Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight

Schizophrenia Clinical Trial

— CRESSOB  

Official title:
Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight (CRESSOB)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00584519
Other study ID # A1281162
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2007
Est. completion date June 2009

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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)

Recruitment information / eligibility
Status Completed
Enrollment 430
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• non-interventional
non-interventional

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 12 months
Secondary Cardiovascular Risk 12 months
Secondary To assess the progress of the symptoms and clinical evolution of the disease 12 months
Secondary Patient Functional Impairment 12 months
Secondary Patient Quality of Life 12 months
Secondary Current Pattern of Treatment in this Population 12 months
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