Janssen - Glucose Regulation/Risp/Olanz

Not Applicable

Completed

• Conditions: Schizophrenia; Type 2 Diabetes Mellitus

• Registration Number: NCT00205738
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in individuals with schizophrenia than in healthy subjects or in other psychiatric conditions. Antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Hyperglycemia can contribute to long-term cardiovascular disease risk that may al...

Detailed Description

This proposal aims to use a well-characterized procedure, the modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT), to characterize the glucoregulatory effects of the two most commonly prescribed atypical antipsychotic medications, risperidone and olanzapine, in comparison to the conventional antipsychotic haloperidol. Abnormalities in per...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2000-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients: meets DSM-IV criteria for schizophrenia, any type, or schizoaffective disorder;
2. Aged 18 to 60 years;
3. Able to give informed consent;
4. No medication changes for 2 weeks prior to and during the period of study; 5. Patients: currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic.

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Exclusion Criteria

1. Controls: Axis I psychiatric disorder criteria met except for substance use disorders as below;
2. Meets DSM-IV criteria for the diagnoses of substance abuse or dependence within the past six months;
3. Involuntary legal status (as per Missouri law);
4. The presence of any serious medical disorder that may (as confirmed by peer-reviewed literature) confound the assessment of symptoms, relevant biologic measures or diagnosis; the following conditions are currently identified: insulin- or non-insulin-dependent diabetes mellitus; any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months; any diagnosed cardiac condition causing documented hemodynamic compromise; any diagnosed respiratory condition causing documented or clinically recognized hypoxia; pregnancy or high dose estrogens, fever, narcotic therapy, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, dehydration, epilepsy, endocrine disease, high-dose benzodiazepine therapy (> 25 mg/day of diazepam), or any medical condition known to interfere with glucose utilization;
5. Meets DSM-IV criteria for Mental Retardation (mild or worse).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effects of olanzapine/risperidone/haloperidol on glucose regulation.

Secondary Outcome Measures

Name	Time	Method
Explore Treatment-related effects on glucose effectiveness.

Trial Locations

Locations (1)

Washington University School of Medicine, Psychiatry Dept.; 🇺🇸 St. Louis, Missouri, United States