Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 52-wk Prospective, Randomized, Double-blind, Multicenter Study of Relapse Following Transition From Oral Antipsychotic Medication to 2 Different Doses (25 or 50 mg Every 2 Wks) of Risperidone Long-acting Microspheres (Risperdal� CONSTA�) in Adults With Schizophrenia or Schizoaffective Disorder
Brief Summary: The purpose of this study is to assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.


Options:
A: Inclusion Criteria:

* Patients who meet the diagnostic criteria for schizophrenia according to DSM-IV-TM for at least 1 year before screening
* have a PANSS score of \<120
* have a body mass index (BMI) \>/=15.0 kilogram (kg)/meter (m)2
* and have resided at the same address for at least 30 days

Exclusion Criteria:

* Patients unable to provide their own consent
* have been involuntarily committed to psychiatric hospitalization
* have primary, active DSM-IV-TM diagnosis other than schizophrenia
* who have a DSM-IV-TM diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
* have a history of treatment resistance as defined by failure to respond to 2 adequate trials (minimum of 4 weeks at a therapeutic dose) of different antipsychotic medications
* have a history of any severe preexisting gastrointestinal narrowing or inability to swallow the medication whole with water
* have a history of neuroleptic malignant syndrome (NMS)
* are at significant risk of suicidal or violent behavior
* current presence of any significant or unstable medication condition
* treatment with any protocol disallowed therapies
* clinically significant result from screening laboratory or ECG.
B: Inclusion Criteria:

* Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by the Institutional Review Board/Institutional Ethics Committee \[IRB/IEC\]), prior to the initiation of any protocol-required procedures.
* Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent.
* Subjects with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR) criteria and a history of the illness for at least 3 years prior to screening.
* Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
* Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications; who can read and understand the written word in order to complete patient-reported outcomes measures; and who can be reliably rated on assessment scales.

Exclusion Criteria:

* Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, or amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
* Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
* Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
* Subjects who currently meet DSM-IV-TR criteria for substance dependence, including alcohol and benzodiazepines, but excluding caffeine and nicotine; or 2 positive drug screens for cocaine.
* Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones; or hypersensitivity to antipsychotic agents.
* Subjects with uncontrolled thyroid function abnormalities.
* Subjects with a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose them to undue risk or interfere with study assessments.
* Subjects who are involuntary incarcerated.
* Subjects who have used an investigational agent within 30 days of screening or prior participation in a clinical study with aripiprazole IM depot.
* Subjects with clinically significant abnormalities in laboratory test results, vital signs, or ECG results; and subjects hospitalized for more than 30 days in the 90 days prior to Phase 1.
* Subjects who fail to wash-out from prohibited concomitant medications, including the use of CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers, antipsychotics, antidepressants (including monoamine oxidase inhibitors \[MAOI}), and mood stabilizers during screening and/or Phase 1.
C: Inclusion Criteria:

* Patients diagnosed with schizophrenia or schizoaffective disorder
* stable with respect to disease symptoms and other medical conditions
* stable on any oral antipsychotic drug (except clozapine) for 4 weeks before the study
* patients identify a relative or acquaintance who can complete a questionnaire with additional information about the patient
* if female, using birth control.

Exclusion Criteria:

* Patient is not eligible if currently hospitalized, or was treated for an acute disease-related crisis within the past 4 weeks
* at risk to self or others
* use of injectable antipsychotic drugs or electroconvulsive therapy within past 6 months, or currently using carbamazepineor an oral antipsychotic drug in a dose that is higher than 8 milligrams per day in risperidone equivalents, of long-acting risperidone in an earlier study, of clozapine, or use of investigational drugs within 30 days, or of electroconvulsive therapy within past 6 months
* presence of liver or kidney damage
* history of neuroleptic malignant syndrome
* if pregnant or breast-feeding
* not using birth control
* abusing drugs or alcohol.
D: Inclusion Criteria:

Main inclusion criteria

* The subject has a primary diagnosis of schizophrenia
* The subject experiences clinically significant symptoms
* The subject's medication remained stable for 8 weeks prior to screening
* The subject is currently in the post-acute maintenance phase of his/her disease

Exclusion Criteria:

Main exclusion criteria

* The subject is at significant risk of suicide
* The subject is treatment resistant
* The subject has experienced an acute exacerbation within 8 weeks prior screening
* The subject is unlikely to comply with the protocol
* The subject has a current diagnosis or a history of substance abuse

Answer: C