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Aggressive Treatment of Metabolic Syndrome in Patients Receiving Clozapine for Schizophrenia (ATOMICS)

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ClinicalTrials.gov Identifier: NCT00794963
Recruitment Status : Terminated (Difficulty recruiting)
First Posted : November 21, 2008
Results First Posted : November 18, 2011
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
Peter Manu, Northwell Health

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Pravastatin, Fenofibrate, Metformin, Orlistat, irbesartan Other: As selected by community physician Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aggressive Treatment of Metabolic Syndrome in Patients Treated With Clozapine for Schizophrenia
Study Start Date : November 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

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Drug Information available for: Clozapine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Integrated care
Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
 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.
Usual Care
Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
 Other: As selected by community physician
As selected by community physician


Outcome Measures
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Primary Outcome Measures :
  1. Change in Weight [ Time Frame: baseline and 8 months ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with schizophrenia treated with clozapine; age 19-79

Exclusion Criteria:

  • pregnant women, personal history of/or comorbid eating disorders
Contacts and Locations
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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): NCT00794963


Locations
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United States, New York
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
More Information
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Responsible Party: Peter Manu, Professor of Medicine and Psychiatry, Hofstra NS-LIJ School of Medicine, Northwell Health
ClinicalTrials.gov Identifier: NCT00794963     History of Changes
Other Study ID Numbers: 08-177
First Posted: November 21, 2008    Key Record Dates
Results First Posted: November 18, 2011
Last Update Posted: April 15, 2015
Last Verified: November 2011
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Schizophrenia
Disease
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Orlistat
Irbesartan
Clozapine
Fenofibrate
 Pravastatin
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants