Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374244
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
2006-09-07
Brief Title:
Efficacy of Pimozide Augmentation for Clozapine Partial Response
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Efficacy of Pimozide Augmentation for Clozapine Partial Response
Status:
COMPLETED
Status Verified Date:
2016-02
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 is a 12 week outpatient study for patients with schizophrenia who are on Clozapine but continue to experience symptoms The purpose of this project is to find out if small doses of pimozide an antipsychotic medication taken by mouth will be helpful in reducing symptoms such as hearing voices having trouble in organizing your thoughts lack of interest in life events and social activities compared to placebo an inactive substance sugar pill when added to clozapine in patients with schizophrenia
The participant will be asked to come in once a week to meet with the research staff and study doctor The participant will continue to see your regular clinician during this study for all normal appointments The participant will remain on your current medications throughout the study During the study you will be randomly selected to be put on a small dose of Pimozide or placebo
The participant will be asked to come in once a week to meet with the research staff and study doctor The participant will continue to see your regular clinician during this study for all normal appointments The participant will remain on your current medications throughout the study During the study you will be randomly selected to be put on a small dose of Pimozide or placebo
Detailed Description:
If you choose to participate you will first have screening tests to find out if you are eligible The study physician will do a number of tests including a physical examination a routine medical history lab tests for blood and urine and EKG to monitor your heart and interviews about your physical and mental health
At each visit you will complete an EKG to monitor your heart vital signs and discuss how you are feeling with the research staff and doctor Once a month we will also conduct a slightly longer interview with you about your symptoms and draw one tube of blood to check your Clozapine level At the beginning and end of the study you will do some pencil and paper games called Neurocognitive tests
If you are interested in participating in this study we will go over it in greater detail with you including the possible benefits and risks associated with participating We will make sure you understand the study before you begin This study is completely voluntary which means that you can choose to stop participating in the study at any time
At each visit you will complete an EKG to monitor your heart vital signs and discuss how you are feeling with the research staff and doctor Once a month we will also conduct a slightly longer interview with you about your symptoms and draw one tube of blood to check your Clozapine level At the beginning and end of the study you will do some pencil and paper games called Neurocognitive tests
If you are interested in participating in this study we will go over it in greater detail with you including the possible benefits and risks associated with participating We will make sure you understand the study before you begin This study is completely voluntary which means that you can choose to stop participating in the study at any time
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