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Clinical Trials/EUCTR2006-001661-41-SE
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.

Registry
who.int
Start Date
March 27, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Karolinska University Hospital

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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