Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 2-year, Prospective, Blinded-rater, Open-label, Active-controlled, Multicenter, Randomized Study of Long-term Efficacy and Effectiveness Comparing Risperdal® Consta® and Abilify® (Aripiprazole) in Adults With Schizophrenia
Brief Summary: The purpose of this study is to compare the effectiveness of two antipsychotic medications, RisperdalÂ® ConstaÂ® versus AbilifyÂ®, over a 2-year treatment period in the long-term maintenance of patients with schizophrenia.


Options:
A: Inclusion Criteria:

* Patients with diagnosis of schizophrenia
* Patient has had at least 2 psychotic relapses in the two years prior to study entry
* patient is not adequately benefiting from their current antipsychotic medication

Exclusion Criteria:

* Patients that have been hospitalized or had major medication changes within 2 months of study entry
* Patients currently experiencing, or who have experienced worsening of disease symptoms within 2 months of study entry
* Patients currently using clozapine or carbamazepine
* Patients who have undergone electroconvulsive therapy or depot antipsychotic treatment within 6 months prior to study entry
* pregnant or breast-feeding
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:

1. Age 18 years or older.
2. Diagnosed with schizophrenia or schizoaffective disorder by the Structured Clinical Interview for Diagnosis (SCID) (Spitzer and First et al., 1996).
3. Patients should

   1. have been hospitalized in the two years before study entry on a psychiatric inpatient unit, or
   2. document explicit current evidence of increased use of outpatient services such as additional visits, day treatment or non-hospital residential treatment, increased dosage of medications or addition of concomitant psychotropic medications.

   The b criterion will promptly be adjudicated by the study chairmen on a case-by case basis to insure credibility.
4. .Adequate transportation is available and the participant lives within a travel time of less than 1.5 hours, allowing attendance at all scheduled visits.
5. Use of an acceptable method of birth control by female patients who have a possibility of becoming pregnant (safety concerns).
6. Able to demonstrate decisional capacity in order to give informed consent as assessed by the MacArthur Competence Assessment Tool (MacCAT) (Appelbaum and Grisso, 1996). Guardian consent is acceptable where applicable.
7. Dually diagnosed patients with both schizophrenia and addictive disorders would be included in this study but should not be in need of acute detoxification for physiologic substance dependence (excluding nicotine) in the past 30 days.

Exclusion Criteria:

1. Physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion).
2. Intolerance of risperidone.
3. Intolerance of intramuscular injection.
4. Current treatment with depot antipsychotic medication.
5. Current treatment with oral clozapine or presence of refractory schizophrenia that, in the treating psychiatrist's opinion, requires clozapine.
6. Hepatic or renal problems AST or ALT (\>2 times upper limit of normal);
7. Elevated bilirubin (\>1.2), BUN (\>24), creatinine (\>1.7).
8. Unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care.
9. Dementia, epilepsy, insulin-dependent diabetes, anticoagulation with coumadin.
10. Unstable living arrangements or not planning to remain in the area for the next year.
11. Legal entanglements or pending legal charges with potential of incarceration.
12. Assault or suicide gesture currently needing acute intervention.
13. Concurrent participation in another clinical trial with an investigational drug during the last 30 days.
14. Pregnant or lactating women or women planning to become pregnant.
D: 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.

Answer: A