EUCTR2006-001661-41-SE
Active, not recruiting
Not Applicable
Body Composition and Metabolic Changes During Antipsychotic Treatment.A Randomized Trial Comparing Sertindole and Olanzapine.
Karolinska University Hospital0 sitesMarch 27, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Karolinska University Hospital
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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