Body Composition and Metabolic Changes During Antipsychotic Treatment.A Randomized Trial Comparing Sertindole and Olanzapine.

Karolinska University Hospital0 个研究点开始时间: 2006年3月27日最近更新: 2012年3月19日

试验速览

暂无简介。

•1. Patients with schizophrenia diagnosis (DSM-IV)
•2. Age between 18 and 65 years
•3. BMI < 35 kg/m2
•4. Patient already treated with an antipsychotic drug (not olanzapine or sertindole) but due to intolerance needs a change of antipsychotic drug.
•5. Signed informed consent to participate in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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

发起方

Karolinska University Hospital