Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

NCT00910988

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hyperglycemia, Hyperlipidemia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males aged 18-45 years

- BMI approximately ≥ 25 and < 35

- insulin approximately ≥ 15 µU/ml or triglyceride approximately ≥ 130 mg/dl

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


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Hyperglycemia, HyperlipidemiaHealthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
NCT00910988
  1. Saint Louis, Missouri
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
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, MDWashington University School of Medicine and Florida Atlantic University
Principal Investigator:Ginger Nicol, MDWashington 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