Augmenting Clozapine With Sertindole - SERCLOZ
- Registration Number
- NCT00345982
- Lead Sponsor
- University of Aarhus
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- QTc >500 ms
- Violence to SPC of clozapine or Serdolect
- Major depression
- Significant substance misuse interfering with participating in the study
- Cardiovascular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Serdolect Sertindole 16 mg B placebo Placebo
- Primary Outcome Measures
Name Time Method PANSS total score 12 weeks
- Secondary Outcome Measures
Name Time Method GAF 12 weeks WHOQOL-BREF 12 weeks CGI 12 weeks DAI 12 weeks Cognitive test 12 weeks Fasting glucose 12 weeks Lipids 12 weeks Hb1Ac 12 weeks
Trial Locations
- Locations (1)
Aalborg Psychiatric Hospital
🇩🇰Aalborg, Denmark