Augmenting Clozapine With Sertindole - SERCLOZ

Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study

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.

Inclusion Criteria:

• ICD10 diagnosis of schizophrenia (F20.0-3)
• Clozapine treatment minimum 6 months
• Total PANSS >65
• No antipsychotic other than clozapine drug 1 month prior inclusion

Exclusion Criteria:

• QTc >500 ms
• Violence to SPC of clozapine or Serdolect
• Major depression
• Significant substance misuse interfering with participating in the study
• Cardiovascular disease