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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00584519
• Collaborator: (none)
• Enrollment: 430
• Duration (Months): 24

Study Details

Study Description

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	Phase
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)

Study Design

• 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: Jun 1, 2007
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	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

Outcome Measures

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. [12 months]

Secondary Outcome Measures

1. Cardiovascular Risk [12 months]

2. To assess the progress of the symptoms and clinical evolution of the disease [12 months]

3. Patient Functional Impairment [12 months]

4. Patient Quality of Life [12 months]

5. Current Pattern of Treatment in this Population [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00584519
• Other Study ID Numbers: A1281162
• First Posted: Jan 2, 2008
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Schizophrenia, Overweight, Cardiovascular Risk, Obesity
• Additional relevant MeSH terms: Overweight; Schizophrenia

Study Results

No Results Posted as of Feb 21, 2021