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

This study has been terminated.
(Difficulty recruiting)
Information provided by (Responsible Party):
Peter Manu, North Shore Long Island Jewish Health System Identifier:
First received: November 19, 2008
Last updated: April 14, 2015
Last verified: November 2011
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: 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 Northwell Health:

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


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

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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Please refer to this study by its identifier: NCT00794963

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 Identifier: NCT00794963     History of Changes
Other Study ID Numbers: 08-177
Study First Received: November 19, 2008
Results First Received: July 19, 2011
Last Updated: April 14, 2015

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Hypolipidemic Agents
Lipid Regulating Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents processed this record on May 25, 2017