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Glucose Regulation During Risperidone and Olanzapine Treatment

This study is currently recruiting participants.
Verified by National Center for Research Resources (NCRR), December 2003

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Janssen, LP
Washington University School of Medicine
Information provided by: National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT00006195
  Purpose

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.


Condition Intervention
Schizophrenia
Drug: risperidone
Drug: olanzapine

MedlinePlus related topics:   Schizophrenia   

ChemIDplus related topics:   Risperidone    Olanzapine    Dextrose   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label

Further study details as provided by National Center for Research Resources (NCRR):

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.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006195

Contacts
Contact: John Newcomer, M.D.     1-314-362-2459     newcomej@psychiatry.wustl.edu    

Locations
United States, Missouri
Washington University     Recruiting
      St. Louis, Missouri, United States, 63110
      Contact: John Newcomer, M.D.            

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Janssen, LP
Washington University School of Medicine
  More Information


Study ID Numbers:   NCRR-M01RR00036-0752, M01RR00036
First Received:   September 7, 2000
Last Updated:   October 11, 2006
ClinicalTrials.gov Identifier:   NCT00006195
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Olanzapine
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 03, 2008




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