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Antipsychotics and Gene Expression in Soft Tissues | Clinical Trials | Clareo Health

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Antipsychotics and Gene Expression in Soft Tissues

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

NCT01185743•Medical University of Vienna

View on ClinicalTrials.gov

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

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

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).
+6 more criteria

Locations (1)

Medical University of Vienna

Vienna, Vienna, Austria

Key Dates

Start Date

July 1, 2010

Primary Completion Date

January 1, 2017

Completion Date

January 1, 2017

Last Updated

March 23, 2017

Enrollment

ACTUAL participants

Conditions

SchizophreniaDiabetes

Interventions

olanzapine

DRUG

ziprasidone

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Antipsychotics and Gene Expression in Soft Tissues

Inclusion Criteria

Exclusion Criteria

Genetic Studies of Insulin and Diabetes

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