Clinical trial NCT01185743: Antipsychotics and Gene Expression in Soft Tissues
Official title: Effect of Atypical Antipsychotics on Gene Expression in Soft Tissues of Healthy Subjects - A Placebo Controlled Randomised Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Diabetes
Keywords: healthy volunteers
antipsychotics
gene expression
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-08-20
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: gene expression profiling
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Martin Brunner, MD
role: PRINCIPAL_INVESTIGATOR
References: