Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158223
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2005-09-07
Brief Title:
Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Pimozide Augmentation of Clozapine in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2015-04
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:
This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia
Detailed Description:
A significant number of schizophrenics exhibit partial or no response to typical antipsychotic medications Clozapine has been shown to be more effective in treating schizophrenia than typical antipsychotic drugs However only an estimated 30 to 60 of people who are unresponsive to treatment with typical antipsychotics will respond to treatment with clozapine Taking clozapine with pimozide an antipsychotic drug can increase clozapines effects However sufficient research on this approach has not yet been performed This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia
Participants in this double-blind study will receive a stable dose of clozapine for eight weeks prior to enrollment For the first 4 weeks following enrollment baseline measurements will be taken Once a week participants will report to the study site where symptom severity cognitive ability and functional status including reading level will be assessed In addition participants will receive a standard medical examination which will include blood tests and an EKG Upon completion of this initial phase participants will be randomly assigned to one of two treatment groups clozapine combined with pimozide or clozapine combined with placebo This phase will last for 12 weeks Study visits will continue to occur weekly and will be used to re-assess the measurements obtained during baseline In addition participants will have an EKG at each study visit for the first 4 weeks of treatment All baseline measurements will be repeated in Week 12
Participants in this double-blind study will receive a stable dose of clozapine for eight weeks prior to enrollment For the first 4 weeks following enrollment baseline measurements will be taken Once a week participants will report to the study site where symptom severity cognitive ability and functional status including reading level will be assessed In addition participants will receive a standard medical examination which will include blood tests and an EKG Upon completion of this initial phase participants will be randomly assigned to one of two treatment groups clozapine combined with pimozide or clozapine combined with placebo This phase will last for 12 weeks Study visits will continue to occur weekly and will be used to re-assess the measurements obtained during baseline In addition participants will have an EKG at each study visit for the first 4 weeks of treatment All baseline measurements will be repeated in Week 12
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH067806 | NIH | None | httpsreporternihgovquickSearchR01MH067806 |