Phase 2
Completed N=28
Efficacy of Pimozide Augmentation for Clozapine Partial Response
Source: ClinicalTrials.gov NCT00374244 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Brief Psychiatric Rating Scale (BPRS) Total Score — 44.1; 44.3 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Psychiatric Rating Scale (BPRS) Total Score |
37.9; 39.6 | — |
| PRIMARY Scale for the Assessment of Negative Symptoms (SANS) |
36.3; 37.3 | — |
| SECONDARY CGI Severity of Illness Scale (CGI-S) |
3.9; 3.9 | — |
| SECONDARY CGI Improvement Scale (CGI-I) |
2.8; 3.4 | — |
| SECONDARY Verbal Fluency |
12.3; 11.1 | — |
| SECONDARY QTc |
412.9; 420.3 | — |
| SECONDARY Processing Speed |
46.5; 42.8 | — |
| SECONDARY Verbal Learning and Memory: List A |
38.0; 32.3 | — |
| SECONDARY Verbal Learning and Memory: List B |
3.4; 3.9 | — |
| SECONDARY Trail Making Test: Trail A |
3.6; 3.8 | — |
| SECONDARY Trail Making Test: Trail B |
4.6; 4.9 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00374244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.