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

NCT00584519 | Completed

• 1 other identifier: A1281162
• Study Type: observational
• Target: 430
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

Schizophrenia, Overweight, Cardiovascular Risk, Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cardiovascular Risk

  12 months

• To assess the progress of the symptoms and clinical evolution of the disease

  12 months

• Patient Functional Impairment

  12 months

• Patient Quality of Life

  12 months

• Current Pattern of Treatment in this Population

  12 months

Study Arms (1)

500 patients

Patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR) with BMI (body mass index) more or equal to 25 Kg/m2

Other: non-interventional

Interventions

non-interventional OTHER

non-interventional

500 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community sample. Patients \>17 years older with diagnosis of Schizophrenia (DSM-IV TR) and Overweight (BMI more or equal to 25 Kg/m2)

You may qualify if:

• 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

You may not qualify if:

• Patients are unable to complete or to understand health questionnaires in Spanish language
• Patients are currently enrolled on clinical trials or other investigational studies

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Schizophrenia; Overweight; Obesity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: June 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 21, 2021

Record last verified: 2021-02