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Antipsychotics and Gene Expression in Soft Tissues

This study has suspended participant recruitment.
(interim analysis)
Sponsor:
Information provided by (Responsible Party):
Martin Bauer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01185743
First received: August 19, 2010
Last updated: September 21, 2015
Last verified: September 2015
  Purpose

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 Intervention Phase
Schizophrenia
Diabetes
Drug: olanzapine
Drug: ziprasidone
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • gene expression profiling [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 42
Study Start Date: July 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: olanzapine
olanzapine
Drug: olanzapine
olanzapine 10mg od + placebo od
Other Name: n.a.
Drug: ziprasidone
ziprasidone 40mg td
Active Comparator: ziprasidone
ziprasidone
Drug: olanzapine
olanzapine 10mg od + placebo od
Other Name: n.a.
Drug: ziprasidone
ziprasidone 40mg td
Placebo Comparator: Sugar pill
Sugar pill
Drug: placebo
placebo td

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185743

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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 
Study First Received: August 19, 2010
Last Updated: September 21, 2015
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
healthy volunteers
antipsychotics
gene expression

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Olanzapine
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
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

ClinicalTrials.gov processed this record on December 02, 2016