|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | North Shore Long Island Jewish Health System |
|---|---|
| Information provided by (Responsible Party): | Peter Manu, North Shore Long Island Jewish Health System |
| ClinicalTrials.gov Identifier: | NCT00794963 |
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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations 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 |
| Study First Received: | November 19, 2008 |
| Results First Received: | July 19, 2011 |
| Last Updated: | November 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
