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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

Page last updated: August 20, 2015

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