Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00345982
Status:
COMPLETED
Last Update Posted:
2010-09-27
First Post:
2006-06-28
Brief Title:
Augmenting Clozapine With Sertindole - SERCLOZ
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None