Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-Blind Randomized Placebo Controlled Study of Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia
Brief Summary: The purpose of this study is to determine whether aripiprazole augmentation is safe and effective in the treatment of clozapine-treated patients with refractory schizophrenia.


Options:
A: Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV criteria
* Any schizoaffective disorder or subtype
* Score greater than 60 on the Positive and Negative Syndrome Scale (PANSS)
* Currently taking clozapine
* Score of four or higher on two or more items from the positive symptom subscale of the PANSS
* Score of 4 or greater on the Clinical Global Impression (CGI) scale
* Clozapine plasma level greater than 378 µg/ml
* Stable dose of clozapine demonstrated to have been associated with a clozapine plasma level greater than 378 µg/ml for at least eight weeks
* Able to read at an 8th grade level or above

Exclusion Criteria:

* History of unstable coronary artery disease
* Congestive heart failure
* History of long Q-T syndrome
* History of cardiac arrhythmia
* History of cardiac conduction delay
* Baseline QT correction score greater than 0.425 seconds
* Liver disease
* History of stroke
* History of Neuroleptic Malignant Syndrome
* Hypokalemia
* Hypocalcemia
* Current blindness, deafness, language difficulties, or any other disability which may prevent participation or cooperation in the study
* Current suicidal or homicidal thoughts
* Currently abusing psychoactive substances
* Currently receiving antidepressants, thymoleptics, L-DOPA, buspirone, or antipsychotics other than clozapine (Valproic acid and Divalproex sodium are not criteria for exclusion)
B: Inclusion Criteria:

* Male or female patients, 18-65 years of age.
* Patients must have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
* Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
* Patients must have a baseline (day 0) BPRS score of at least 35 or over 2 of 5 SANS global rating item scores of at least 3.
* Patients have been receiving clozapine treatment for more than 1 year and there has been no change in clozapine dosage for more than 3 months.
* Patients must have a history of antipsychotic treatment with at least 2 different kinds prior to clozapine administration.
* Subjects who are fluent in Korean.

Exclusion Criteria:

* DSM-IV substance (except nicotine or caffeine) dependence within the past 1 year.
* Female patients who are either pregnant or lactating.
* Mental retardation (IQ \< 70).
* Neurological disorders including epilepsy, stroke, or severe head trauma.
* Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis and EKG.
* Prior history of aripiprazole non-response or intolerance.
* BPRS score of \< 35 and over 4 of 5 SANS global rating item scores of \< 3.
* Participation in a clinical trial of another investigational drug within 3 months (90 days) prior to study entry.
* Treatment with an injectable depot neuroleptic within less than three dosing interval between the last depot neuroleptic injections and baseline (day 0).
* History of electroconvulsive therapy within the past 3 months.
* Subjects who are not fluent in Korean.
C: Inclusion Criteria:

* Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
* Stable symptoms and dose of Quetiapine or Risperidone

Exclusion Criteria:

* First diagnosis in the past year
* Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse
D: Inclusion Criteria:

* Subject ≥ 18 years of age.
* Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.
* Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.

Exclusion Criteria:

* Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening.
* Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.
* Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).

Answer: B