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.
Sponsor:
Information provided by:
Janssen, LP
ClinicalTrials.gov Identifier:
NCT00236379
First received: October 7, 2005
Last updated: May 16, 2011
Last verified: March 2011

October 7, 2005
May 16, 2011
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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 ]
Change in the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test (which shows how the body regulates glucose) over 6 months.
Complete list of historical versions of study NCT00236379 on ClinicalTrials.gov Archive Site
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 ]
  • 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.
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A Study of the Effects of Risperidone and Olanzapine on Blood Glucose (Sugar) in Patients With Schizophrenia or Schizoaffective Disorder
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

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Schizophrenia
  • Diabetes Mellitus
  • Drug: Olanzapine
    Target oral dose of 20 milligrams per day for 6 months
  • Drug: Risperidone
    Target oral dose of 6 milligrams per day for for 6 months
  • Experimental: 001
    Risperidone Target oral dose of 6 milligrams per day for for 6 months
    Intervention: Drug: Risperidone
  • Experimental: 002
    Olanzapine Target oral dose of 20 milligrams per day for 6 months
    Intervention: Drug: Olanzapine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
August 2003
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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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00236379
CR002758
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Janssen, LP
Not Provided
Study Director: Janssen, LP Clinical Trial Janssen, LP
Janssen, LP
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP