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OpenTrials
Completed

NCT Number: NCT01185743

Antipsychotics and Gene Expression in Soft Tissues

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 signs of impaired glucose tolerance as evaluated by Oral Glucose Tolerance Test (OGTT) before study inclusion during screening, normal total cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), triglycerides, normal function of the thyroid. No personal or family history (parents and siblings) of diabetes or other metabolic and relevant diseases as defined by the investigator.
  • No indication for psychiatric diseases assessed by structured clinical interview (Mini-International Neuropsychiatric Interview (MINI)).

Exclusion criteria

  • 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.
  • Nicotine consumption at time of enrolment (at least 3 months of non-smoking required).

Treatment and study plan

Olanzapine

Drug

olanzapine 10mg od + placebo od

Ziprasidone

Drug

ziprasidone 40mg td

Placebo

Drug

placebo td

Primary outcomes

  1. gene expression profiling

    Time frame: 10 days

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effect of Atypical Antipsychotics on Gene Expression in Soft Tissues of Healthy Subjects - A Placebo Controlled Randomised Pilot Study

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Aug 20, 2010
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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