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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00584519
First received: December 21, 2007
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Schizophrenia
 Other: non-interventional

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight (CRESSOB)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular Risk [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess the progress of the symptoms and clinical evolution of the disease [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient Functional Impairment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Current Pattern of Treatment in this Population [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 430
Study Start Date: June 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
non-interventional

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584519

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00584519     History of Changes
Other Study ID Numbers: A1281162
Study First Received: December 21, 2007
Last Updated: July 6, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Pfizer:
Schizophrenia, Overweight, Cardiovascular Risk, Obesity

Additional relevant MeSH terms:
Schizophrenia
Overweight
Schizophrenia and Disorders with Psychotic Features
 Mental Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013