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Glucose Regulation During Risperidone and Olanzapine Treatment

NCT ID: NCT00006195

Last Updated: 2006-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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risperidone

Intervention Type DRUG

olanzapine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen, LP

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Locations

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Washington University

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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John Newcomer, M.D.

Role: CONTACT

Phone: 1-314-362-2459

Email: [email protected]

Facility Contacts

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John Newcomer, M.D.

Role: primary

Other Identifiers

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M01RR000036

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCRR-M01RR00036-0752

Identifier Type: -

Identifier Source: org_study_id