Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

NCT00910988 | Completed Results

• 1 other identifier: 08-0540
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Hyperlipidemia

Keywords

healthy; sedentary; men; acute effects of antipsychotic; blood sugar; insulin sensitivity

Outcome Measures

Primary Outcomes (4)

• Whole Body Insulin Sensitivity

  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).

  approximately 3 hours

• Hepatic Insulin Sensitivity

  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 \[Ra\]).

  approximately 3 hours

• Peripheral Insulin Sensitivity

  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 \[Rd\]).

  approximately 3 hours

• Adipose Tissue Insulin Sensitivity

  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 \[Ra\]).

  approximately 3 hours

Study Arms (3)

olanzapine

ACTIVE COMPARATOR

olanzapine injection in healthy control

Drug: Olanzapine

ziprasidone

ACTIVE COMPARATOR

ziprasidone injection in healthy control

Drug: Ziprasidone

saline

PLACEBO COMPARATOR

saline injection in healthy control

Drug: Olanzapine; Drug: Ziprasidone

Interventions

Olanzapine DRUG

olanzapine/Zyprexa

Also known as: Zyprexa

olanzapine; saline

Ziprasidone DRUG

ziprasidone/Geodon

Also known as: Geodon

saline; ziprasidone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Pfizer: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Hyperlipidemias; Sedentary Behavior; Multiple Endocrine Neoplasia Type 1; Insulin Resistance

Interventions

Olanzapine; ziprasidone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Behavior; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Julie Schweiger/Michael Yingling
• Organization: Washington University

schweigj@psychiatry.wustl.edu/yinglinm@psychiatry.wustl.edu

3143623153/5735791412

Study Officials

• John W Newcomer, MD

  Washington University School of Medicine and Florida Atlantic University

  PRINCIPAL INVESTIGATOR

• Ginger Nicol, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: June 1, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 18, 2018
• Results First Posted: January 15, 2014

Record last verified: 2018-06

Locations

US (1)