Augmenting Clozapine With Sertindole - SERCLOZ
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: A Sertindole 16 mg |
Drug: Serdolect
16 mg, 12 weeks
Other Names:
|
Placebo Comparator: B Placebo |
Drug: placebo
placebo
|
Outcome Measures
Primary Outcome Measures
- PANSS total score [12 weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Aalborg Psychiatric Hospital | Aalborg | Denmark | 9000 |
Sponsors and Collaborators
- University of Aarhus
- H. Lundbeck A/S
Investigators
- Principal Investigator: Jimmi Nielsen, M.D., Aalborg Psychiatric Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2005/150