Augmenting Clozapine With Sertindole - SERCLOZ
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Serdolect (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s): Jimmi Nielsen, M.D., Principal Investigator, Affiliation: Aalborg Psychiatric Hospital
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.
Clinical Details
Official title: Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: PANSS total score
Secondary outcome: GAFWHOQOL-BREF CGI DAI Cognitive test Fasting glucose Lipids Hb1Ac
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Aalborg Psychiatric Hospital, Aalborg 9000, Denmark
Additional Information
Starting date: September 2006
Last updated: September 24, 2010
|