CClinicalTrials.gg
Status unknownNCT00006195Updated Oct 12, 2006

Glucose Regulation During Risperidone and Olanzapine Treatment

An interventional study of risperidone and olanzapine in Schizophrenia, sponsored by National Center for Research Resources (NCRR). Status unknown at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-10-12.

Sponsored by National Center for Research Resources (NCRR) · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2003), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

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Lead sponsor

National Center for Research Resources (NCRR) is the lead sponsor of 265 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • Drugrisperidone
  • Drugolanzapine
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Study locations

1 of 1 sites recruiting
  • Washington University
    St. Louis, Missouri 63110, United States
    • John Newcomer, M.D. · Contact
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00006195
Lead sponsor
National Center for Research Resources (NCRR)
Collaborators
Janssen, LP, Washington University School of Medicine
First posted
Sep 8, 2000
Last update
Oct 12, 2006

Study contacts

John Newcomer, M.D.
Contact
newcomej@psychiatry.wustl.edu
1-314-362-2459
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2003. You cannot join it, but the record below documents what was studied.

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