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

• Conditions: Patients with schizophrenia diagnosis (DSM-IV)

• Registration Number: EUCTR2006-001661-41-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified