Status:
COMPLETED
Augmenting Clozapine With Sertindole - SERCLOZ
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
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 sch...
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 tr...
Eligibility Criteria
Inclusion
- 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
- QTc \>500 ms
- Violence to SPC of clozapine or Serdolect
- Major depression
- Significant substance misuse interfering with participating in the study
- Cardiovascular disease
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00345982
Start Date
September 1 2006
End Date
September 1 2010
Last Update
September 27 2010
Active Locations (1)
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1
Aalborg Psychiatric Hospital
Aalborg, Denmark, 9000