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Trial record 1 of 1 for:    NCT00910988
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Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

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ClinicalTrials.gov Identifier: NCT00910988
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : January 15, 2014
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE February 3, 2009
First Posted Date  ICMJE June 1, 2009
Results First Submitted Date  ICMJE April 11, 2013
Results First Posted Date  ICMJE January 15, 2014
Last Update Posted Date July 18, 2018
Study Start Date  ICMJE February 2009
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • Whole Body Insulin Sensitivity [ Time Frame: approximately 3 hours ]
    To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min).
  • Hepatic Insulin Sensitivity [ Time Frame: approximately 3 hours ]
    To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance [Ra]).
  • Peripheral Insulin Sensitivity [ Time Frame: approximately 3 hours ]
    To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance [Rd]).
  • Adipose Tissue Insulin Sensitivity [ Time Frame: approximately 3 hours ]
    To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance [Ra]).
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2009)
blood sugar [ Time Frame: approximately 8 hours ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2009)
insulin sensitivity and signaling [ Time Frame: approximately 8 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
Official Title  ICMJE A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers
Brief Summary

Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production (glucose rate of appearance [Ra]), primarily muscle glucose utilization (glucose rate of disappearance [Rd]), and adipose tissue related free fatty acid production (glycerol rate of appearance [Ra]).

We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in insulin sensitivity.

Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling pathways in antipsychotic naïve healthy young men.

We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in insulin signaling.

Detailed Description See brief description
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Hyperglycemia
  • Hyperlipidemia
Intervention  ICMJE
  • Drug: Olanzapine
    olanzapine/Zyprexa
    Other Name: Zyprexa
  • Drug: Ziprasidone
    ziprasidone/Geodon
    Other Name: Geodon
Study Arms  ICMJE
  • Active Comparator: olanzapine
    olanzapine injection in healthy control
    Intervention: Drug: Olanzapine
  • Active Comparator: ziprasidone
    ziprasidone injection in healthy control
    Intervention: Drug: Ziprasidone
  • Placebo Comparator: saline
    saline injection in healthy control
    Interventions:
    • Drug: Olanzapine
    • Drug: Ziprasidone
Publications * Not Provided

*   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: November 26, 2013)
46
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2009)
96
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males aged 18-45 years
  • BMI approximately ≥ 25 and < 35
  • insulin approximately ≥ 15 µU/ml or triglyceride approximately ≥ 130 mg/dl

Exclusion Criteria:

  • Any DSM-IV Axis I diagnosis
  • prisoners
  • any serious medical disorder (i.e. metabolic diseases, type 1 or 2 diabetes mellitus, endocrine disease, coagulopathy, clinically significant anemia, acute infection)
  • taking prescription medications
  • non-sedentary lifestyle with > 3 hours of exercise per week
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 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 NCT00910988
Other Study ID Numbers  ICMJE 08-0540
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, MD Washington University School of Medicine and Florida Atlantic University
Principal Investigator: Ginger Nicol, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date June 2018

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