Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
Brief Summary: The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.


Options:
A: Inclusion Criteria:

* Patients who have provided informed consent prior to any study specific procedures
* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
* Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
* Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
* Patients in their first episode of psychosis
* Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
* Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
* Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
* Substance abuse or dependence within the prior 3 months
B: Inclusion Criteria:

* Male or female patients, from 18 to 65 years of age at Visit 1
* Patients must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
* Patients must agree to cooperate with all tests and examinations required by the protocol. They must be willing to comply fully with treatment
* Patient must understand the nature of the study and must sign an informed consent document.
* Patients must be Cantonese speaking Han Chinese
* Patients must be diagnosed, according to the SCID for DSM-IV, with schizophrenia, schizoaffective disorder or schizophreniform psychosis.
* Patients must have good response to anti-psychotic treatment by achieving a rating of 2 or below in Clinical Global Impression Scale (CGI) Severity of illness; a rating of 4 or below in Improvement scale, and a rating of 3 or below in (conceptual disorganization, unusual thought content), a rating of 2 or below in (delusion, hallucinatory behavior) and a rating of 4 or below in (Suspiciousness) of Positive and Negative Syndrome Scale (PANSS) for at least 8 weeks

Exclusion Criteria:

* Female patients who are either pregnant or lactating.
* Patients previously on clozapine should be excluded from the study
* Significant medical illnesses including seizures.
* DSM-IV substance (alcohol or other drugs) abuse or dependence within the past 3 months.
* Judged clinically to be at serious suicidal risk.
* Treatment with an injectable depot neuroleptic within less than one of the patient's dosing intervals between depot neuroleptic injections prior to study entry.
C: Inclusion Criteria:

* Must meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) for 1 year (the diagnosis will be established using the K-SADS-PL, including all supplements)
* Must not be a danger to themselves or others, and must have family support available to be maintained as an outpatient
* Should have had at least 1 adequate treatment with an antipsychotic before participation in this study
* Must have a PANSS score between 60 and 120, inclusive, at screening and baseline
* Weight \>=29 kg

Exclusion Criteria:

* Meet the DSM-IV criteria at screening for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance induced psychotic disorder. Other comorbid disorders e.g., attention-deficit hyperactivity disorder (ADHD) are allowed as long as the diagnosis of schizophrenia is the primary diagnosis and the comorbid disorders in the investigator's judgment do not require medication
* Mild, moderate, or severe mental retardation (i.e., documented intelligence quotient \[IQ\] \<70) established by previous IQ testing or history
* Women who are pregnant (as confirmed by urine pregnancy test performed at screening or baseline), planning to become pregnant or are nursing
* Have a known or suspected history of seizure disorder, or neuroleptic malignant syndrome, encephalopathic syndrome, tardive dyskinesia, or insulin dependent diabetes mellitus
* Presence of any significant or unstable cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
D: Inclusion Criteria:

* Patients age 18 years or older to less than 65 years, inclusive (at time of informed consent)
* Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening (as per subject, family, healthcare provider, or by previous medical records).
* Subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
* Subjects who showed previous response to antipsychotic treatment in the past year.
* Subjects who are currently treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic treatment with antipsychotic medication for stabilization.
* Subjects who are experiencing a current acute exacerbation of psychotic symptoms requiring stabilization
* Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

Exclusion Criteria:

* Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
* Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
* Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
* Subjects experiencing acute depressive symptoms within the past 30 days
* Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history
* Subjects with a significant risk of violent behavior; who represent a risk of committing suicide
* Subjects with clinically significant tardive dyskinesia
* Subjects currently treated with insulin for diabetes.

Answer: A