Pfizer/IVGTT/Ziprasidone/Olanzapine
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Type 2 Diabetes Mellitus
Intervention: Ziprasidone, Olanzapine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s): John W. Newcomer, M.D., Principal Investigator, Affiliation: Washington University School of Medicine and Florida Atlantic University
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 already be increased in patients with schizophrenia due to higher rates of smoking,
sedentary life style, obesity and under-treated hypertension and dyslipidemia. This project
will characterize the effects on glucose control of the two most commonly prescribed newer
antipsychotic medications, ziprasidone and olanzapine, in patients with schizophrenia.
Clinical Details
Official title: Glucose Regulation During Ziprasidone Treatment
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Effects of olanzapine/ziprasidone/haloperidol on glucose regulation
Secondary outcome: Explore treatment-related effects on glucose effectiveness
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, ziprasidone and
olanzapine, in comparison to the conventional antipsychotic haloperidol. 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. While
abnormalities in glucose regulation were first reported in schizophrenia prior to the
introduction of antipsychotic medications, antipsychotic treatment may contribute
significantly to abnormalities in glucose regulation.
Recently, the adverse effect of antipsychotic medications on systemic glucose regulation has
received increased attention as investigators noted prominent adverse glucoregulatory
effects associated with certain newer antipsychotic medications. Abnormal glucose
regulation and new-onset type 2 diabetes have been reported during clozapine and olanzapine
treatment. Complicating the study of antipsychotic-induced changes in glucose regulation,
increased adiposity can decrease insulin sensitivity, and antipsychotics can increase
adiposity and body mass index (BMI). However, abnormal glucose regulation and type 2
diabetes can occur during clozapine treatment in the absence of weight gain, suggesting that
changes in glucose regulation can occur independent of drug-induced increases in BMI.
Consistent with this, our preliminary studies indicate that important effects of clozapine
and olanzapine on glucose regulation are not accounted for by differences in BMI. This
proposal will compare the effects of olanzapine, ziprasidone and haloperidol on well-defined
measures of glucose regulation.
This proposal specifically hypothesizes that olanzapine treatment will be associated with
decreases in insulin sensitivity (SI), without effects on insulin secretion.
Treatment-related effects on glucose effectiveness (SG) will be explored.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients: meets DSM-IV criteria for schizophrenia, any type, or schizoaffective
disorder;
- aged 18 to 60 years;
- able to give informed consent;
- no medication changes for 2 weeks prior to and during the period of study;
- Patients: currently taking an antipsychotic.
Exclusion Criteria:
- Controls: Axis I psychiatric disorder criteria met except for substance use disorders
as below;
- meets DSM-IV criteria for the diagnoses of substance abuse or dependence within the
past six months;
- involuntary legal status (as per Missouri law);
- 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;
- meets DSM-IV criteria for Mental Retardation (mild or worse).
Locations and Contacts
Washington University School of Medicine, Psychiatry Dept., St. Louis, Missouri 63110, United States
Additional Information
Starting date: November 2000
Last updated: March 12, 2014
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