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A Study of the Effects of Risperidone and Olanzapine on Blood Glucose (Sugar) in Patients With Schizophrenia or Schizoaffective Disorder
This study has been completed.
First Received: October 7, 2005   Last Updated: May 11, 2007   History of Changes
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: risperidone; olanzapine
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:


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) over 6 months.

Secondary Outcome Measures:
  • Changes in measurements of metabolism and glucose regulation
  • changes in results of tests and questionnaires that evaluate the effectiveness and safety (including laboratory tests and anthropomatic measurements) of medications used to treat schizophrenia.

Estimated Enrollment: 60
Estimated Study Completion Date: August 2003
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:
No publications provided

Study ID Numbers: CR002758
Study First Received: October 7, 2005
Last Updated: May 11, 2007
ClinicalTrials.gov Identifier: NCT00236379     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen, LP:
olanzapine
glucose metabolism
blood glucose
risperidone
schizophrenia
diabetes mellitus

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Schizophrenia
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Metabolic Diseases
Tranquilizing Agents
Gastrointestinal Agents
Risperidone
Diabetes Mellitus
Endocrine System Diseases
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Glucose Metabolism Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010