Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
Brief Summary: The purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.


Options:
A: Inclusion Criteria:

* In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.

Exclusion Criteria:

* Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT.
* Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
* Contraindications or non-responsiveness for any of the treatments or other safety issues
* Expected non-compliance to treatment and/or study procedures
B: Inclusion Criteria:

* Primary diagnosis of Acute Bipolar I Mania

Exclusion Criteria:

* Patients with a DSM-IV diagnosis other than Bipolar I Mania
C: 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.
D: Inclusion Criteria:

* Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or similar psychotic disorder not otherwise specified, as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P)
* History of previous antipsychotic medication treatment for a duration of 2 weeks or less
* Current positive symptoms rated 4 (moderate) or more on one or more of the following Brief Psychiatric Rating Scale (BPRS-A) items: conceptual disorganization; grandiosity; hallucinatory behavior; or unusual thought content
* Agrees to use an effective form of contraception

Exclusion Criteria:

* Any serious neurological or endocrine disorder, or any medical condition or treatment known to affect the brain
* Any current medical condition that requires treatment with a medication with psychotropic effects
* At significant risk for suicidal or homicidal behavior
* Cognitive or language limitations, or any other factor that would interfere with a participant's ability to provide informed consent or safely participate in study procedures
* Diagnosis of diabetes, defined as a fasting plasma glucose level of at least 126 mg/dL, or metabolic syndrome, defined as three or more of the following: high blood pressure (greater than 135/85 mmHg); truncal obesity (having a waist circumference greater than 40 inches for men and greater than 35 inches for women); elevated fasting glucose (greater than 110 mg/dL); low HDL-cholesterol (less than 40 mg/dL for men and less than 50 mg/dL for women); or elevated triglycerides (defined as greater than 150 mg/dL)
* Requires treatment with an antidepressant or mood stabilizing medication
* Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features
* Any medical conditions that would make treatment with risperidone or aripiprazole medically inadvisable

Answer: B