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Aggressive Treatment of Metabolic Syndrome in Patients Receiving Clozapine for Schizophrenia

NCT00794963 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-04-15

Study results available
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Summary

Schizophrenia patients treated with clozapine have a high prevalence of obesity-related metabolic syndrome. The condition is often poorly treated and may lead to the emergence of coronary heart disease and type 2 diabetes. The study will investigate whether structured treatment provided at the site of the outpatient psychiatric clinic of metabolic syndrome in this population will decrease the severity of metabolic syndrome as compared with usual care received by these patients in the community.

Conditions

  • Metabolic Syndrome

Interventions

DRUG

Pravastatin, Fenofibrate, Metformin, Orlistat, irbesartan

The intervention in the 4 patients consisted in dietary recommendations, advice regarding increasing physical activity, and use of Orlistat 60 mg three times daily. No other drugs were prescribed.

OTHER

As selected by community physician

As selected by community physician

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00794963 on ClinicalTrials.gov