NCT00297960

Brief Summary

Healthy volunteers will undergo euglycaemic hyperinsulinaemic clamp and microdialysis before and after administration of 10mg olanzapine or 80mg ziprasidone during 10 days.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
Last Updated

October 18, 2006

Status Verified

October 1, 2005

First QC Date

February 28, 2006

Last Update Submit

October 17, 2006

Conditions

Healthy Male Volunteers

Interventions

ziprasidone or olanzapineDRUG
hyperinsulinaemic euglycaemic clampPROCEDURE
microdialysis (skeletal muscle)PROCEDURE

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-55
  • Healthy male volunteers
  • No history of drug or alcohol abuse
  • No regular nicotine consumption at time of enrollment
  • Physical activity at least twice a week
  • Body mass Index between 19-24 kg/m2
  • Normal laboratory values
  • Normotension (blood pressure less than 140/90)
  • No past or present history of psychiatric disorder
  • No family history of diabetes or obesity
  • Written informed consent

You may not qualify if:

  • Use of medication within the last 14 days
  • Consumption of alcohol within the last 5 days
  • Family history of diabetes or obesity
  • Past or present psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University Vienna

Vienna, 1090, Austria

Location

Related Publications (3)

  • Newcomer JW, Haupt DW, Fucetola R, Melson AK, Schweiger JA, Cooper BP, Selke G. Abnormalities in glucose regulation during antipsychotic treatment of schizophrenia. Arch Gen Psychiatry. 2002 Apr;59(4):337-45. doi: 10.1001/archpsyc.59.4.337.

    PMID: 11926934BACKGROUND

  • Rosdahl H, Lind L, Millgard J, Lithell H, Ungerstedt U, Henriksson J. Effect of physiological hyperinsulinemia on blood flow and interstitial glucose concentration in human skeletal muscle and adipose tissue studied by microdialysis. Diabetes. 1998 Aug;47(8):1296-301. doi: 10.2337/diab.47.8.1296.

    PMID: 9703331BACKGROUND

  • Muller M, Holmang A, Andersson OK, Eichler HG, Lonnroth P. Measurement of interstitial muscle glucose and lactate concentrations during an oral glucose tolerance test. Am J Physiol. 1996 Dec;271(6 Pt 1):E1003-7. doi: 10.1152/ajpendo.1996.271.6.E1003.

    PMID: 8997218BACKGROUND

MeSH Terms

Interventions

ziprasidoneOlanzapineMicrodialysis

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDialysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Siegfried Kasper, Prof. MD

    Medical University Vienna, Department of General Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2006

First Posted

March 1, 2006

Study Start

April 1, 2005

Last Updated

October 18, 2006

Record last verified: 2005-10

Locations

AU(1)