Antipsychotics and Gene Expression in Soft Tissues

Phase 4

Completed

• Conditions: Diabetes; Schizophrenia
• Interventions: Drug: placebo; Drug: olanzapine; Drug: ziprasidone

• Registration Number: NCT01185743
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-20
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	placebo	Sugar pill
ziprasidone	olanzapine	ziprasidone
olanzapine	ziprasidone	olanzapine
olanzapine	olanzapine	olanzapine
ziprasidone	ziprasidone	ziprasidone

Primary Outcome Measures

Name	Time	Method
gene expression profiling	10 days	To characterize and compare the gene expression profiles in human subcutaneous adipose and muscle tissue prior and after single dose of olanzapine, ziprasidone and placebo.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria