Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00910988
First received: February 3, 2009
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Hyperglycemia
Hyperlipidemia
Drug: Olanzapine
Drug: Ziprasidone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Whole Body Insulin Sensitivity [ Time Frame: approximately 3 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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]).


Enrollment: 46
Study Start Date: February 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: olanzapine
olanzapine injection in healthy control
Drug: Olanzapine
Active Comparator: ziprasidone
ziprasidone injection in healthy control
Drug: Ziprasidone
Placebo Comparator: saline
saline injection in healthy control
Drug: Olanzapine Drug: Ziprasidone

Detailed Description:

See brief description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910988

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Pfizer
Investigators
Principal Investigator: John W Newcomer, MD Washington University School of Medicine
Principal Investigator: Ginger Nicol, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00910988     History of Changes
Other Study ID Numbers: 08-0540
Study First Received: February 3, 2009
Results First Received: April 11, 2013
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
healthy
sedentary
men
acute effects of antipsychotic
blood sugar
insulin sensitivity

Additional relevant MeSH terms:
Hyperglycemia
Hyperlipidemias
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Hyperinsulinism
Olanzapine
Ziprasidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 29, 2014