Weight gain and calory intake induction in subject taking Olanzapine are treated with Topiramate for reversal off effects
Conditions
Interventions
Group 1: An oral dose of 10 mg olanzapine once daily on Days 1-14 and 1 capsule of placebo twice daily on Days 1-6 and 2 capsules of placebo twice daily on Days 7-14.
Group 2: On Days 1-6: an oral do
Sponsors
Top Institute Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gender: Male; 2. Age: 20-55 years, inclusive; 3. Body mass index (BMI): 22-30 kg/m2; 4. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research centre until discharge; 5. Medical history without major pathology; 6. Blood pressure and resting pulse rate showing no clinically relevant deviations as judged by the Medical Investigator (MI); 7. Computerised (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the MI; 8. All values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the MI; 9. Have serum prolactin and serum ALAT, ASAT, alkaline phosphatase and bilirubin values at screening less than upper limit of normal (ULN); 10. Willingness to sign the written Informed Consent Form (ICF); 11. Understanding of written and spoken Dutch language.
Exclusion criteria
Exclusion criteria: 1. Evidence of clinically relevant pathology; 2. Mental handicap; 3. History of psychiatric diseases with or without medical treatment; 4. Significant psychopathology (=admission to psychiatric facility) in first grade family members; 5. History of relevant drug and/or food allergies; 6. Regular/routine treatment with non-topical medications within 30 days prior to drug administration; 7. Have an abnormally low blood pressure with significant orthostatic change (systolic blood pressure decrease of >30 mm Hg on standing up for 3 minutes; 8. Smoking (less than 60 days prior to drug administration); 9. History of alcohol abuse or drug addiction (including soft drugs like cannabis products); 10. Use of concomitant medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entrance into the research facility. All other medication (including over the counter medication, health supplements, and herbal remedies such as St. John’s Wort extract) must have been stopped at least 14 days prior to the first dose. The use of a limited amount of acetaminophen is permitted; 11. Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies in the 10 months preceding the start of this study (this is the first administration of study drug); 12. Donation of more than 50 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood in the 10 months preceding the start of this study; 13. Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol; 14. Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits); 15. Positive screen on HBsAg; 16. Positive screen on anti HCV; 17. Positive screen on anti HIV 1/2; 18. Illness within 5 days prior to the first drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effects of 14 days of daily dosing of 10 mg olanzapine with or without topiramate on body weight in healthy male subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess if olanzapine at a dose of 10 mg daily for 14 days with or without topiramate has an effect on thyroid function, glucose and lipid metabolism in healthy male subjects. | — |
Contacts
Public ContactEdith Gelens
Stationsweg 163
Outcome results
None listed