Aggressive Treatment of Metabolic Syndrome in Patients Receiving Clozapine for Schizophrenia

NCT00794963 | Terminated Results

• 1 other identifier: 08-177
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  baseline and 8 months

Study Arms (2)

Integrated care

EXPERIMENTAL

Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic

Drug: Pravastatin, Fenofibrate, Metformin, Orlistat, irbesartan

Usual Care

OTHER

Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community

Other: As selected by community physician

Interventions

Pravastatin, Fenofibrate, Metformin, Orlistat, irbesartan DRUG

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.

Integrated care

As selected by community physician OTHER

As selected by community physician

Usual Care

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnant women, personal history of/or comorbid eating disorders

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Pravastatin; Fenofibrate; Metformin; Orlistat; Irbesartan

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Phenols; Ketones; Biguanides; Guanidines; Amidines; Lactones; Biphenyl Compounds; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Peter Manu, MD
• Organization: North Shore Long Island Jewish Health System, Zucker Hillside Hospita, Glen Oaks, NY

718 470-8290 pmanu@nshs.edu

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Psychiatry, Hofstra NS-LIJ School of Medicine

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 21, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 15, 2015
• Results First Posted: November 18, 2011

Record last verified: 2011-11

Locations

US (1)