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

This study has been terminated.
(Difficulty recruiting)
Sponsor:
Information provided by (Responsible Party):
Peter Manu, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00794963
First received: November 19, 2008
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in Weight [ Time Frame: baseline and 8 months ] [ Designated as safety issue: No ]

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.
No Intervention: 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

Ages Eligible for Study:   19 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794963

Locations
United States, New York
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
North Shore Long Island Jewish Health System
  More Information

No publications provided

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
Study First Received: November 19, 2008
Results First Received: July 19, 2011
Last Updated: November 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aggression
Schizophrenia
Metabolic Syndrome X
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Clozapine
Orlistat
Metformin
Fenofibrate
Pravastatin
 Irbesartan
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on May 21, 2013