Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study to Determine the Efficacy, Tolerability and Safety of Low and High Non-overlapping Dose Ranges of BL-1020 Compared to Placebo and Risperidone
Brief Summary: This is a prospective, six-week, randomized, double blind, placebo-controlled, multi-center study in patients with schizophrenia who are experiencing an acute exacerbation of psychosis.


Options:
A: Inclusion criteria:

* SCID diagnosis of schizophrenia or schizoaffective disorder
* Partially remitted outpatients, defined as persons who have received clear symptomatic benefit from antipsychotic medication but remain symptomatic (due to lack of efficacy or inability to tolerate an efficacious dose) or suffer significant side effects
* Treatment with antipsychotic medications for at least 2 months
* Received at least 1 outpatient mental health service every 3 months for the past 6 months

Exclusion criteria:

* Severe symptoms or side effects that indicate the necessity for a medication change
* Currently taking 3 or more antipsychotic medications for ongoing daily administration (PRN medications and mood stabilizers are allowable)
* Treatment with clozapine
* One or more nights spent in a psychiatric hospitalization within the past 3 months
* Received services from a crisis intervention program within the past 3 months
* Require placement in a skilled nursing facility as a result of a physical condition or disability
* Criminal charges pending (once charges clear, the person will be considered)
* Pregnant or breast feeding
* Contraindication to any of the medications to which the patient might be assigned
B: Inclusion Criteria:

* Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria as specified by the protocol for at least 1 year before screening
* Prior medical records, written documentation or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
* A total PANSS score between 60 and 120, inclusive, at screening and baseline; Body mass index (BMI) at the screening visit BMI at least 17 kg/m2
* Female patients must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study as specified by the protocol. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hCG) pregnancy test result at screening.

Exclusion Criteria:

* Patient unable to provide consent or involuntarily committed to psychiatric hospitalization; A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
* A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
* History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
* Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease including history of neuroleptic malignant syndrome; History of any severe pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole with the aid of water (applies to those patients requiring oral tolerability only)
* Significant risk of suicidal or violent behavior, as clinically assessed by the investigator ; History of life-threatening allergic reaction to any drug; Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20% Intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, and glycerol)
* Have received an experimental drug or experimental biologic, or used an experimental medical device within 6 months before screening; History of any active malignancy within the previous 5 years, with the exception of basal cell carcinomas
* Women who are pregnant or breast-feeding or are planning to become pregnant uring the study
C: Inclusion Criteria:

* Subjects with a diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria.
* Men and women, aged 18-65 years.
* Subjects must be able to give written informed consent.
* Subjects must be inpatients.
* Subjects must have adequate data to assess healthcare resource utilization for the previous 10 months.
* Subjects must have been previously treated with (and tolerated) oral risperidone.
* Results of standard clinical laboratory tests are to be within the laboratory's reference range or, if outside this range, judged by the investigator to be not clinically significant.

Exclusion Criteria:

Exclusion Criteria:

* Subjects with significant alcohol or substance abuse in the past 3 months.
* Subjects with other psychiatric, medical or behavioural comorbid disorder that in the opinion of the investigator may interfere with study conduct or interpretation (such as delirium, stroke, developmental disability).
* Subjects who are pregnant, breast-feeding, or women of child-bearing potential not using adequate contraception.
* Subjects with known hypersensitivity or allergy to risperidone.
* Subjects with tardive dyskinesia or a history of neuroleptic malignant syndrome.
* Subjects with a known history of being unresponsive to risperidone.
* Subjects with a clinically significant electrocardiogram abnormality.
D: Inclusion Criteria:

* Patient is male or female, 18-65 years of age, inclusive.
* If female, the patient must be post-menopausal, or if fecund, must be abstinent or practicing an established method of birth control such as hormonal preparations (e.g., oral contraceptive tablets, hormonal implant device, hormone patch, or injectable contraceptive), or intrauterine device \[IUD\], for at least two months prior to screening, and in addition must use a barrier method, e.g., condom, diaphragm, contraceptive foam.
* Patient is willing and able to provide informed consent, after the nature of the study has been fully explained.
* Patient is an inpatient or outpatient who has a current DSM-IV-TR diagnosis of schizophrenia, as confirmed by the MINI-Plus.
* Patient must be experiencing an acute exacerbation of psychosis, with a baseline (Study Day 0) total score on the PANSS greater than '70'.
* Patient must have a score of '4' ("moderate") or more at baseline on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/persecution, where at least one of the two items must be either delusions or hallucinatory behaviors, and the total score on the four items must be greater than '17'.
* Patient must be experiencing an acute exacerbation of psychosis with a total score on the CGI-S of '4' ("moderate") or greater at baseline.
* Patient is willing to be hospitalized at screening, and willing to remain in the hospital at least 14 days after baseline (through Study Day 14) as clinically indicated, and must be willing to comply with all study related evaluations and procedures through Study Day 42.
* Patient has a caregiver or an identified responsible person (e.g., family member, social worker, nurse) who will support him/her to ensure compliance with the treatment and outpatient visits.
* Patient is willing to comply with not taking any prohibited medications during participation in the study.

Exclusion Criteria:

* The presence of any of the following will exclude a patient from study enrolment:

General

* Patient is unwilling or unable to provide informed consent.
* Patient is unwilling or unable, in the opinion of the Investigator, to comply with study instructions.
* If female, patient is pregnant, breast-feeding, has a positive urine pregnancy test at screening or baseline, or is of reproductive capacity and is unwilling to comply with accepted contraceptive methods during the study, ie, not using an oral contraceptive, hormonal patch or implant, injectable contraceptive or IUD, in combination with a barrier method (see Inclusion Criterion #2).
* Patient has made a plasma or blood donation within 14 days prior to the screening visit.
* Patient has participated in a prior clinical study of BL-1020 or any of its excipients, and/or has received an investigational drug within thirty days prior to screening.
* Patient is judged by the PI to be inappropriate for the study.

Answer: D