Please select the eligibility criteria that correspond to the clinical trial below.
Title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
Brief Summary: The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.


Options:
A: 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.
B: Inclusion Criteria:

* Patients must understand and be capable 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, be willing to comply fully with treatment and able to ingest oral medication.
* Patients must understand the nature of the study and must sign an informed consent document.
* Patients will have a clear diagnosis of schizophrenia according to DSM-IV criteria for at least 1 year.
* Patients must need of ongoing psychiatric treatment and must have a documented reason why a change in treatment is needed which might lead to a clinical improvement
* At screening patients will have a Positive and Negative Syndrome Scale (PANSS) of no more than 100 and a Clinical Global Impression Scale (CGI) of no more than 5 (i.e. must not be severely ill or worse).
* Patients must be outpatients at the time of screening and have not been an inpatient to treat schizophrenia for at least 1 week prior to the screening visit.
* Patients must have a history of at least 2 prior episodes of relapse or impending relapse in the 2 years preceding the screening visit.

Exclusion Criteria:-

* Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study.
* Patients who meet the DSM-IV criteria for schizophreniform disorder (295.40) and schizoaffective (295.70).
* Patients with active symptoms of any other primary psychiatric diagnosis (Axis I) or prominent Axis II disorder which would interfere with compliance to the protocol.
* Patients who have a diagnosis or history suggestive of chemical dependence, or drug-induced toxic psychosis in the preceding 6 months; diagnosis or history of abuse (except for nicotine and caffeine) within the past 3 months, or a clinical presentation possibly confounded by the use of recreational drugs or alcohol.
* Patients who have a positive urine drug screen (at the screening visit). If opiates are positive at screening and clearly due to the use of pain killing medication, the patient may be re screened after the medication has been discontinued and enrolled in the study if urine drug screen is negative.
* Note: Occasional users of recreational drugs other than cocaine, amphetamines, hallucinogens, or parenteral drugs may be recruited. Patients who are dependent on nicotine, caffeine, or theophylline are allowed to enter the study.
* Patients who are mentally disabled (moderate to severe).
* Patients who have had a history of being in a coma for more than 24 hrs.
* Patients who have had thoughts of committing suicide within 6 months prior to screening or at baseline or suicide behaviors within 2 years prior to screening or at baseline.
* Patients thought to be of imminent risk of harm to others or in imminent legal difficulty.
* Patients under any form of legal compulsion to remain hospitalized or undergo treatment or assessment.
* Patients who have any disability that prevent them from completing any of the study requirements.
* Patients with a known clinically significant ECG abnormality including PR interval \>240 msec, QRS complex \>110 msec, QTcF \>=450 msec, or congenital long QT syndrome based on central ECG reading results
* Treatment naive, first episode patients,
* Patients taking iloperidone at the screening visit or with a known hypersensitivity to drugs chemically related to benzioxazoles.
* Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the patient or the study results.

Other protocol-defined inclusion/exclusion criteria may apply
C: Inclusion Criteria:

* Patients with schizophrenia for more than 1 year
* A total score in the Positive and Negative Syndrome Scale (PANSS) \< 120
* Signed informed consent
* Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
* Men must agree to use a double-barrier method of birth control
* Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
* A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
* Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
* A diagnosis of substance dependence within 6 months before screening
* History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
* Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
* Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
* Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
D: Inclusion Criteria:

* Confirmed SCID DSM-IV clinical diagnosis by trained remote clinical assessor of:

  * schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder NOS
* Any duration of untreated psychosis
* Any ethnicity
* Ability to participate in research assessments in English
* Ability to provide fully informed consent (assent for those under age 18)

Exclusion Criteria:

* Inability to understand what research participation entails or correctly answer the questions about research participation that are part of the Study Information Review and provide fully informed consent
* More than 4 months of prior cumulative treatment with antipsychotic medications
* Diagnosis of bipolar disorder, psychotic depression or substance-induced psychotic disorder
* Current psychotic disorder due to a general medical condition
* Current neurological disorders that would affect diagnosis or prognosis. These would include, but are not limited to seizure disorders, dementing or degenerative disorders, lesions or substantial congenital abnormalities. In most cases, disorders such as headache disorders would not require protocol exclusion
* Clinically significant head trauma
* Any other serious medical condition that in the opinion of the investigator would seriously impair functioning making the patient unsuitable for the trial

Answer: D