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

NCT00584519

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients are unable to complete or to understand health questionnaires in Spanish
language


- Patients are currently enrolled on clinical trials or other investigational studies

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Advanced Information
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 CenterPfizer
PRS Account Pfizer
Verification Date July 2010