Patients with schizophrenia diagnosis (DSM-IV)
Conditions
Interventions
Product Name: Serdolect
Pharmaceutical Form: Tablet
INN or Proposed INN: Sertindole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Product Name: Zyprexa
Pharma
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with schizophrenia diagnosis (DSM-IV) 2. Age between 18 and 65 years 3. BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Manifest cardiovascular diseases 2. Abnormal ECG 3. Heredity for prolonged QTc time 4. Prolonged QTc time (males > 450ms; females >470ms) 5. Treated with medications that prolong the QTc time (lithium, macrolides, antihistamines, quinolones, cisapride, methadone, tricyclic antidepressants) 6. Allergic to sertindole or olanzapine 7. Liver failure 8. Glaucoma 9. Previously prescribed either olanzapine or sertindole 10. On clozapine treatment during the last 3 weeks 11. Hypokalemia or hypomagnesemi 12. Bradychardia (<50 beats per minute) 13. Heart failure 14. Hypertrophic heart disease 15. Treatment with potent CYP3A4 inhibitors or cytochrome p450 influencing drugs (azol-antimyotics (systemic treatment), macrolide antibiotics, HIV-protease inhibitors, Ca-channel blockers, cimetidine 16. Treatment with potent CYP2D6 influencing agents ( fluoxietine, paroxetine and venlafaxine) while allowing agents without potent action ( citalpopram and mirtazepam) 17. Parkinson’s disease 18. Depot antipsychotic medications during the last 4 weeks 19. Pregnancy or breastfeeding 20. Diagnosed with type 2 diabetes 21. Diagnosed with cancer 22. Treated at the same time with another antipsychotic drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the short- and long-term effects on body composition in schizophrenic patients treated with either Sertindole or Olanzapine. ;Secondary Objective: To measure changes in metabolic markers, inflammation markers, blood pressure, physical activity, quality of life and overall effectiveness.;Primary end point(s): The primary end point will be change in body composition (truncal fat mass and total fat mass). Differences between groups at each time-point as well as the change trajectory over the full period will be investigated. | — |
Countries
Sweden
Outcome results
None listed