Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight
NCT00584519
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Adult Trials: 18+ Years
- 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
- 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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| 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 | 430 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2021 | |||