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

NCT ID: NCT00584519

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

Brief Summary

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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

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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)

Conditions

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Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

non-interventional

Intervention Type OTHER

non-interventional

Interventions

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non-interventional

non-interventional

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A1281162

Identifier Type: -

Identifier Source: org_study_id

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