Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00584519
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

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.


Condition or disease Intervention/treatment
Schizophrenia Other: 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)

Layout table for study information
Study Type : Observational
Actual Enrollment : 430 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight (CRESSOB)
Study Start Date : June 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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. [ Time Frame: 12 months ]

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


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00584519    
Other Study ID Numbers: A1281162
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Schizophrenia, Overweight, Cardiovascular Risk, Obesity
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight