Antipsychotics and Gene Expression in Soft Tissues

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Diabetes; Schizophrenia

Treatments: Drug: olanzapine; Drug: ziprasidone; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01185743

OLA_ZIPRA

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 3 patient groups, including a placebo group

olanzapine

Active Comparator group

Description:

olanzapine

Treatment:

Drug: olanzapine

Drug: ziprasidone

ziprasidone

Active Comparator group

Description:

ziprasidone

Treatment:

Drug: olanzapine

Drug: ziprasidone

Sugar pill

Placebo Comparator group

Description:

Sugar pill

Treatment:

Drug: placebo