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Antipsychotics and Gene Expression in Soft Tissues

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ClinicalTrials.gov Identifier: NCT01185743
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : March 23, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Diabetes Drug: olanzapine Drug: ziprasidone Drug: placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Atypical Antipsychotics on Gene Expression in Soft Tissues of Healthy Subjects - A Placebo Controlled Randomised Pilot Study
Study Start Date : July 2010
Primary Completion Date : January 1, 2017
Study Completion Date : January 1, 2017

Arms and Interventions

Arm Intervention/treatment
Active Comparator: olanzapine
Drug: olanzapine
olanzapine 10mg od + placebo od
Drug: ziprasidone
ziprasidone 40mg td
Active Comparator: ziprasidone
Drug: olanzapine
olanzapine 10mg od + placebo od
Drug: ziprasidone
ziprasidone 40mg td
Placebo Comparator: Sugar pill
Sugar pill
Drug: placebo
placebo td

Outcome Measures

Primary Outcome Measures :
  1. gene expression profiling [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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).
  • 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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185743

Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Martin Brunner, MD Medical University of Vienna
More Information

Responsible Party: Martin Bauer, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01185743     History of Changes
Other Study ID Numbers: OLA_ZIPRA
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Martin Bauer, Medical University of Vienna:
healthy volunteers
gene expression

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents