NCT01185743

Brief Summary

Schizophrenia is a severe chronic and disabling mental disorder and is associated with a significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid metabolism. Aim: to gain data on drug related effects on gene expression and regulation with special regard to glucose metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_4 schizophrenia

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

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

6.5 years

First QC Date

August 19, 2010

Last Update Submit

March 22, 2017

Conditions

SchizophreniaDiabetes

Keywords

healthy volunteersantipsychoticsgene expression

Outcome Measures

Primary Outcomes (1)

  • gene expression profiling

    To characterize and compare the gene expression profiles in human subcutaneous adipose and muscle tissue prior and after single dose of olanzapine, ziprasidone and placebo.

    10 days

Study Arms (3)

olanzapine

ACTIVE COMPARATOR

olanzapine

Drug: olanzapineDrug: ziprasidone

ziprasidone

ACTIVE COMPARATOR

ziprasidone

Drug: olanzapineDrug: ziprasidone

Sugar pill

PLACEBO COMPARATOR

Sugar pill

Drug: placebo

Interventions

olanzapineDRUG

olanzapine 10mg od + placebo od

olanzapineziprasidone
ziprasidoneDRUG

ziprasidone 40mg td

olanzapineziprasidone
placeboDRUG

placebo td

Sugar pill

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male.
  • Healthy, defined as absence of relevant diseases.
  • Caucasian.
  • Aged 18-45 years.
  • Body-Mass-Index (BMI): 18-25 kg/m2.
  • Signed informed consent.
  • No indication for psychiatric diseases assessed by structured clinical interview (Mini-International Neuropsychiatric Interview (MINI)).

You may not qualify if:

  • Personal or family history (parents and siblings) of diabetes or other metabolic diseases, relevant diseases as defined by the investigator.
  • History of hypertension, blood pressure \> 140/90 at screening, cardiovascular disease.
  • Body mass index out of the range of \<18 and \>25 kg/m.
  • Human immunodeficiency virus (HIV) or Hepatitis B/C positive virology.
  • Allergy or hypersensitivity against olanzapine/ziprasidone or another excipient.
  • Contraindications against the use of the drug according to the Summary of Product Characteristics (SmPC).
  • Any drug intake 2 weeks prior to first study day.
  • History of excessive bleeding tendency/hemophilia.
  • Presence of relevant illness within the last 3 weeks.
  • Currently enrolled into an other clinical study with Investigational Medicinal Products (IMPs).
  • Last study participation less than 4 weeks.
  • Suspected non-compliance with study instructions and life-style requirements.
  • History of alcohol or drug abuse.
  • Blood/Plasma donation within 4 weeks prior to study day.
  • Previous exposure to antipsychotic drugs.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

SchizophreniaDiabetes Mellitus

Interventions

Olanzapineziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Martin Brunner, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 20, 2010

Study Start

July 1, 2010

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations

AU(1)