A Study of the Effects of Risperidone and Olanzapine on Blood Glucose (Sugar) in Patients With Schizophrenia or Schizoaffective Disorder - Full Text View

Sponsor:	Janssen, LP
Information provided by:	Janssen, LP
ClinicalTrials.gov Identifier:	NCT00236379

Purpose

The purpose of this study is to assess and compare how risperidone and olanzapine, two antipsychotic medications, affect the regulation of glucose (sugar) in the body.

Condition	Intervention	Phase
Schizophrenia Diabetes Mellitus	Drug: Olanzapine Drug: Risperidone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Six-month, Double-blind, Randomized, International, Multicenter Trial to Evaluate the Glucoregulatory Effects of Risperidone and Olanzapine in Subjects With Schizophrenia or Schizoaffective Disorder

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Schizophrenia

Drug Information available for: Dextrose Risperidone Olanzapine

U.S. FDA Resources

Further study details as provided by Janssen, LP:

Primary Outcome Measures:

Change in the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test (which shows how the body regulates glucose) [ Time Frame: Up to 6 months ]

Secondary Outcome Measures:

Changes in measurements of metabolism and glucose regulation; changes in results of tests and questionnaires evaluating the effectiveness and safety (including laboratory tests and anthropomatic measurements) of medications used to treat schizophrenia [ Time Frame: Up to 6 months ]

Enrollment:	59
Study Completion Date:	August 2003

Arms	Assigned Interventions
Experimental: 001 Risperidone Target oral dose of 6 milligrams per day for for 6 months	Drug: Risperidone Target oral dose of 6 milligrams per day for for 6 months
Experimental: 002 Olanzapine Target oral dose of 20 milligrams per day for 6 months	Drug: Olanzapine Target oral dose of 20 milligrams per day for 6 months

Detailed Description:

The newer antipsychotic medications risperidone and olanzapine effectively treat schizophrenia and related disorders, and they may cause fewer side effects than the older antipsychotic drugs do. However, some of the newer antipsychotic medications could have a negative effect on the regulation of blood glucose (sugar) in the body. This negative effect could make the patient gain weight and even develop diabetes mellitus. This randomized, double-blind study will assess and compare how risperidone and olanzapine affect the regulation of glucose in the body in patients with schizophrenia and schizoaffective disorder. Patients will be randomly assigned to receive risperidone (target oral dose of 6 milligrams per day) or olanzapine (target oral dose of 20 milligrams per day) for 6 months. Repeat laboratory measurements will be performed and questions will be asked of the patients to evaluate the safety and effectiveness of the drugs. The primary laboratory test used to assess the patient's regulation of blood glucose will be the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test. Risperidone 2 milligram oven-encapsulated tablets taken orally once a day for 6 months; olanzapine 5 milligram tablets taken orally once a day for 6 months

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of schizophrenia or related disorder
stable with respect to disease symptoms and other medical conditions
would benefit from this type of antipsychotic drug
if female, using birth control.

Exclusion Criteria:

Patients who are delirious, bipolar, severely mentally retarded, or suicidal
psychiatric diagnosis of disease unrelated to schizophrenia
presence of stroke, brain tumor, Parkinson's Disease, or diseases that affect blood glucose control
history of diabetes
long or recent history of taking risperidone, olanzapine, quetiapine, clozapine, or investigational drugs
recent history of unstable thyroid function
if female, not using birth control
abusing drugs or alcohol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236379

Sponsors and Collaborators

Janssen, LP

Investigators

Study Director:

Janssen, LP Clinical Trial

Janssen, LP

More Information

Additional Information:

A Six-Month, Double Blind, Randomized, International, Multicenter Trial to Evaluate the Glucoregulatory Effects of Risperidone and Olanzapine in Subjects with Schizophrenia or Schizoaffective disorder. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00236379 History of Changes
Other Study ID Numbers:	CR002758
Study First Received:	October 7, 2005
Last Updated:	May 16, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Janssen, LP:

schizophrenia
blood glucose
glucose metabolism

diabetes mellitus
risperidone
olanzapine

Additional relevant MeSH terms:

Diabetes Mellitus
Psychotic Disorders
Schizophrenia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Olanzapine
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
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012