Effect of atypical antipsychotics on gene expression in soft tissues of healthy subjects. A placebo controlled randomised pilot study. - OLA_ZIPRA

Conditions: The study will be conducted in 42 healthy volunteers

Registration Number: EUCTR2009-011097-15-AT

Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

•Male
•Healthy, defined as absence of relevant diseases
•Caucasian
•Aged 18-45 years
•BMI: 18-25 kg/m2
•Signed informed consent
•No signs of impaired glucose tolerance as evaluated by OGTT before study inclusion during screening, normal total cholesterol, HDL, 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

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, RR > 140/90 at screening, cardiovascular disease
•Body mass index out of the range of <18 and >25 kg/m
•HIV or Hepatitis B/C positive virology
•Allergy or hypersensitivity against olanzapin/ziprasidon or another excipient
•Contraindications against the use of the drug according to the 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
•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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Definition of a set of genes relevant for glucose metabolism regulation based on gene expression data.<br>Comparison of gene expression profiles before and after administration of antipsychotics.<br>Association of adipokine, hormone and biomarker blood levels with gene expression profiles. <br>Differences in body weight under olanzapine or ziprasidone medication<br>;Primary end point(s): gene expression profiles in skeletal muscle and adipose tissue in response to drug treatment with two different antipsychotics;Main Objective: Differences in the soft tissue gene expression profile after administration of olanzapine or ziprasidone after single and multiple dose administration.

Secondary Outcome Measures