Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Pimozide Augmentation for Clozapine Partial Response
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.


Options:
A: Inclusion Criteria:

* DSM-IV criteria for schizophrenia or schizoaffective disorder
* Current clozapine treatment
* Moderate illness severity and inadequate positive symptom response to clozapine treatment
* 6 month period of clozapine treatment with documented clozapine blood level greater than or equal to 350 ng/ml or clozapine and norclozapine blood level greater than or equal to 450 ng/ml

Exclusion Criteria:

* Organic brain disorder
* Mental retardation
* Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
* Pregnancy
* DSM-IV criteria for current alcohol or substance dependence within the last 6 months or DSM-IV criteria for alcohol or substance abuse within the last month
* Previously received adjunctive risperidone (at doses greater than or equal to 8 mg/day) with their clozapine treatment for greater than or equal to 6 weeks
B: 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.
C: Inclusion Criteria:

* Double-blind phase: DSM-IV diagnosis of schizophrenia for at least 1 year
* experiencing an acute episode, with a total PANSS score at screening between 70 and 120
* agree to voluntary hospitalization for a minimum of 14 days. Open-label phase: must have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy.

Exclusion Criteria:

* DSM-IV axis I diagnosis other than schizophrenia
* DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
* history of neuroleptic malignant syndrome (NMS)
* history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
* previous history of lack of response to risperidone when acutely psychotic
* significant risk of suicidal or violent behavior.
D: Inclusion Criteria:

* Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.

Exclusion Criteria:

* Patients known to be allergic to aripiprazole
* Hospitalized patients
* Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.

Answer: B