Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-Blind, Placebo and Active-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 featuring psychomotor agitation, with clinical need for intramuscular injection

Exclusion Criteria:

* delirium, severe or unstable general medical condition, previous history of severe adverse effects with one of the treatment options
B: 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.
C: 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)
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
* Current psychotic episode (schizophrenia exacerbation) \< 2 weeks duration at Visit 1
* Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
* CGI-S score ≥ 4

Exclusion Criteria:

* Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
* Bipolar I and II disorder
* Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
* DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
* Women who are pregnant or breast feeding
D: Inclusion Criteria:

* Subjects treated with clozapine for the indication of poor response to other antipsychotic medications.
* Treatment with clozapine is at a stable dose for at least 12 weeks. Dose must be 400 mg/day or more, unless side effects limited increase of dose.

Exclusion Criteria:

* Subjects with significant alcohol or substance abuse in the past 3 months.
* Subjects with a previous trial of risperidone augmentation of clozapine
* Subjects who are pregnant, breast-feeding, or women of child-bearing potential not using adequate contraception
* Subjects requiring treatment with anticonvulsants.
* Subjects with known hypersensitivity or allergy to risperidone.
* Subjects with hematological or other contraindications to continued clozapine treatment.

Answer: C