Pfizer/IVGTT/Ziprasidone/Olanzapine

NCT00205725

Last updated date
Study Location
Washington University School of Medicine, Psychiatry Dept.
St. Louis, Missouri, 63110, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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[email protected]

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Schizophrenia, Type 2 Diabetes MellitusPfizer/IVGTT/Ziprasidone/Olanzapine
NCT00205725
  1. St. Louis, Missouri
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pfizer/IVGTT/Ziprasidone/Olanzapine
Official Title  ICMJE Glucose Regulation During Ziprasidone Treatment
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 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Type 2 Diabetes Mellitus
Intervention  ICMJE Drug: Ziprasidone, Olanzapine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2013)
120
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
250
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00205725
Other Study ID Numbers  ICMJE Pfizer IVGTT/941273
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:John W. Newcomer, M.D.Washington University School of Medicine and Florida Atlantic University
PRS Account Washington University School of Medicine
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP