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

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ClinicalTrials.gov Identifier: NCT00236379
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Janssen, LP

Tracking Information
First Submitted Date  ICMJE October 7, 2005
First Posted Date  ICMJE October 12, 2005
Last Update Posted Date May 17, 2011
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
Change in the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test (which shows how the body regulates glucose) over 6 months.
Change History Complete list of historical versions of study NCT00236379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2011)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
  • 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.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effects of Risperidone and Olanzapine on Blood Glucose (Sugar) in Patients With Schizophrenia or Schizoaffective Disorder
Official Title  ICMJE 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
Brief Summary 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.
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
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2011)
59
Original Enrollment  ICMJE
 (submitted: October 7, 2005)
60
Actual Study Completion Date August 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00236379
Other Study ID Numbers  ICMJE CR002758
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Janssen, LP
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen, LP Clinical Trial Janssen, LP
PRS Account Janssen, LP
Verification Date March 2011

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