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Antipsychotics and Gene Expression in Soft Tissues

Primary Purpose

Schizophrenia, Diabetes

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
olanzapine
ziprasidone
placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring healthy volunteers, antipsychotics, gene expression

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

olanzapine

ziprasidone

Sugar pill

Arm Description

olanzapine

ziprasidone

Sugar pill

Outcomes

Primary Outcome Measures

gene expression profiling
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.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2010
Last Updated
March 22, 2017
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01185743
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Diabetes
Keywords
healthy volunteers, antipsychotics, gene expression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
olanzapine
Arm Type
Active Comparator
Arm Description
olanzapine
Arm Title
ziprasidone
Arm Type
Active Comparator
Arm Description
ziprasidone
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Sugar pill
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Description
olanzapine 10mg od + placebo od
Intervention Type
Drug
Intervention Name(s)
ziprasidone
Intervention Description
ziprasidone 40mg td
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo td
Primary Outcome Measure Information:
Title
gene expression profiling
Description
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.
Time Frame
10 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Brunner, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Antipsychotics and Gene Expression in Soft Tissues

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