Efficacy of Pimozide Augmentation for Clozapine Partial Response
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Pimozide Augmentation for Clozapine Partial Response|
- Brief Psychiatric Rating Scale (BPRS) [ Time Frame: baseline and monthly ] [ Designated as safety issue: No ]
- Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: baseline and monthly ] [ Designated as safety issue: No ]
- Clinical Global Impression (CGI) [ Time Frame: Baseline and monthly ] [ Designated as safety issue: No ]
- Brief neurocognitive battery [ Time Frame: Baseline and monthly ] [ Designated as safety issue: No ]
- QTC changes [ Time Frame: Baseline and weekly ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2004|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
half of the subjects are randomized to placebo
Active Comparator: 2
half of the subjects are randomized to the active drug
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.
|United States, Connecticut|
|Connecticut Mental Health Center|
|New Haven, Connecticut, United States, 06508|
|VA Connecticut Healthcare System|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Handan Gunduz-Bruce, MD||Yale University School of Medicine, Dept of Psychiatry|