EUCTR2009-011097-15-AT
Active, not recruiting
Not Applicable
Effect of atypical antipsychotics on gene expression in soft tissues of healthy subjects. A placebo controlled randomised pilot study. - OLA_ZIPRA
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie0 sitesAugust 11, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The study will be conducted in 42 healthy volunteers
- Sponsor
- Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy, defined as absence of relevant diseases
- •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
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
Outcomes
Primary Outcomes
Not specified
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