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

This study has been terminated.
(Difficulty recruiting)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00794963
First Posted: November 21, 2008
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Manu, North Shore Long Island Jewish Health System
  Purpose
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 Intervention
Metabolic Syndrome Drug: Pravastatin, Fenofibrate, Metformin, Orlistat, irbesartan Other: As selected by community physician

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Peter Manu, North Shore Long Island Jewish Health System:

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

Enrollment: 8
Study Start Date: November 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Senior)
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
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
United States, New York
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
  More Information

Responsible Party: Peter Manu, Professor of Medicine and Psychiatry, Hofstra NS-LIJ School of Medicine, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00794963     History of Changes
Other Study ID Numbers: 08-177
First Submitted: November 19, 2008
First Posted: November 21, 2008
Results First Submitted: July 19, 2011
Results First Posted: November 18, 2011
Last Update Posted: April 15, 2015
Last Verified: November 2011

Additional relevant MeSH terms:
Syndrome
Schizophrenia
Metabolic Syndrome X
Disease
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Fenofibrate
Pravastatin
Orlistat
Clozapine
Irbesartan
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
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants