Glucose Regulation During Risperidone and Olanzapine Treatment
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
risperidone
olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: meet DSM-IV criteria for schizophrenia, any type, or schizoaffective disorder; able to give informed consent; no medication changes for 2 weeks prior to and during the period of study; currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic
Sites / Locations
- Washington UniversityRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006195
First Posted
September 7, 2000
Last Updated
October 11, 2006
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Janssen, LP, Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00006195
Brief Title
Glucose Regulation During Risperidone and Olanzapine Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Janssen, LP, Washington University School of Medicine
4. Oversight
5. Study Description
Brief Summary
The overall purpose of this research is to look at how two of the most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, affect substances in the body such as glucose and insulin. Undesirable changes in blood sugar control, or glucose regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia compared to healthy subjects and subjects with other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia before the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Attention to the way that antipsychotic medications may affect glucose regulation has increased as doctors have become more concerned in general about disease- and drug-related medical complications, including weight gain during antipsychotic treatment.
Detailed Description
This study will include 70 patients diagnosed with schizophrenia, taking either risperidone, olanzapine or haloperidol, and 20 healthy control subjects. Each subject will undergo a 4 hour glucose tolerance test. In addition, there will be a small project within the overall study to measure the effects of risperidone and olanzapine on glucose regulation as the individuals switch from their prior treatment with a conventional antipsychotic medication to either risperidone or olanzapine. Ten subjects will be studied on a typical neuroleptic at baseline then switched over a one week period to risperidone or olanzapine. The participants will be evaluated at 1 week, 4 weeks, and 12 weeks, prospectively. Each evaluation will consist of a 4 hour glucose tolerance test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Type
Drug
Intervention Name(s)
olanzapine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
meet DSM-IV criteria for schizophrenia, any type, or schizoaffective disorder;
able to give informed consent;
no medication changes for 2 weeks prior to and during the period of study;
currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Newcomer, M.D.
Phone
1-314-362-2459
Email
newcomej@psychiatry.wustl.edu
Facility Information:
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Newcomer, M.D.
12. IPD Sharing Statement
Learn more about this trial
Glucose Regulation During Risperidone and Olanzapine Treatment
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