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Trial record 1 of 1 for:    NCT00584519
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Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight (CRESSOB)

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ClinicalTrials.gov Identifier: NCT00584519
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date December 21, 2007
First Posted Date January 2, 2008
Last Update Posted Date July 7, 2010
Study Start Date June 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2008)
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 ]
Original Primary Outcome Measures
 (submitted: December 21, 2007)
Evolution of modifiable metabolic risk factors (Blood pressure, cigarette smoking, weist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months. [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures
 (submitted: December 21, 2007)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight
Official Title Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight (CRESSOB)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition Schizophrenia
Intervention Other: non-interventional
non-interventional
Study Groups/Cohorts 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
Intervention: Other: non-interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 11, 2009)
430
Original Estimated Enrollment
 (submitted: December 21, 2007)
500
Actual Study Completion Date June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00584519
Other Study ID Numbers A1281162
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2010