Status:
COMPLETED
Efficacy of Pimozide Augmentation for Clozapine Partial Response
Lead Sponsor:
Yale University
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 ...
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 his...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder.
- A minimum Brief Psychiatric Rating Scale (BPRS) score of 35 and a BPRS psychotic symptom cluster score of at least 8.
- Currently taking clozapine with a blood level between 350-1000 ng/ml and on a stable dose of clozapine for the past 2 weeks.
- Able to give informed consent.
Exclusion
- A history of significant medical/neurological disease such as thyroid, renal, hepatic abnormality, seizure disorder.
- History of Neuroleptic Malignant Syndrome.
- Current substance abuse determined by urine toxicology.
- Cardiac arrhythmia, sinus bradycardia (heart rate less than 60/min), sinus tachycardia (heart rate greater than 110/min), supraventricular tachycardia, ventricular tachycardia, Wolff-Parkinson-White Syndrome, first, second, third degree atrioventricular (AV) block, atrial fibrillation, atrial flutter and junctional complexes. in baseline electrocardiogram (EKG). Study doctors will examine the EKGs and consult with an internist/cardiologist as needed.
- on EKG: QTc \> 450 ms.
- Current use of macrolide antibiotics (e.g., erythromycin, clarithromycin), azole antifungal agents (e.g., ketoconazole, itraconazole), protease inhibitors (e.g., ritonavir, indinavir), nefazodone, and other medications that are associated with prolonged QTc.
- Current use of antipsychotics other than clozapine.
- Current use of sertraline.
- IQ level below 70.
- At high risk for suicidal/homicidal behavior.
- Pregnancy, lack of birth control for females of childbearing age (female patients must report use of effective method for birth control such as birth control pills, condoms, barrier methods, abstinence or have written statement from their doctors that they are medically sterile).
- Non-English speaking.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00374244
Start Date
January 1 2004
End Date
June 1 2011
Last Update
March 4 2016
Active Locations (2)
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1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06508
2
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516