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

Completed

• Conditions: Schizophrenia
• Interventions: Other: non-interventional

• Registration Number: NCT00584519
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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)

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-02
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
500 patients	non-interventional	Patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR) with BMI (body mass index) more or equal to 25 Kg/m2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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