Status:
COMPLETED
Antipsychotics and Gene Expression in Soft Tissues
Lead Sponsor:
Medical University of Vienna
Conditions:
Schizophrenia
Diabetes
Eligibility:
MALE
18-45 years
Phase:
PHASE4
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 becaus...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01185743
Start Date
July 1 2010
End Date
January 1 2017
Last Update
March 23 2017
Active Locations (1)
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1
Medical University of Vienna
Vienna, Vienna, Austria, 1090