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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584519
First Posted: January 2, 2008
Last Update Posted: July 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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:


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 ]

Secondary Outcome Measures:
  • Cardiovascular Risk [ Time Frame: 12 months ]
  • To assess the progress of the symptoms and clinical evolution of the disease [ Time Frame: 12 months ]
  • Patient Functional Impairment [ Time Frame: 12 months ]
  • Patient Quality of Life [ Time Frame: 12 months ]
  • Current Pattern of Treatment in this Population [ Time Frame: 12 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584519


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00584519     History of Changes
Other Study ID Numbers: A1281162
First Submitted: December 21, 2007
First Posted: January 2, 2008
Last Update Posted: July 7, 2010
Last Verified: July 2010

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

Additional relevant MeSH terms:
Schizophrenia
Overweight
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight
Signs and Symptoms