The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.
Around 20 % of patients with schizophrenia are treatment-resistant. Clozapine is still the drug of choice for these patients but 2/3 will not respond adequately to clozapine. In the study clozapine treatment is augmented with sertindole. Patients are randomized to either clozapine or sertindole for 12 weeks and continue in a open-label study with sertindole for 12 weeks. The purpose of the open-label study is to determine whether clozapine dosage can be reduced due to the addition of sertindole.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Aalborg Psychiatric Hospital
Aalborg, Denmark
PANSS total score
Time frame: 12 weeks
GAF
Time frame: 12 weeks
WHOQOL-BREF
Time frame: 12 weeks
CGI
Time frame: 12 weeks
DAI
Time frame: 12 weeks
Cognitive test
Time frame: 12 weeks
Fasting glucose
Time frame: 12 weeks
Lipids
Time frame: 12 weeks
Hb1Ac
Time frame: 12 weeks
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