Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness of Long-Acting Risperidone in the Maintenance Treatment of First-Episode Schizophrenia
Brief Summary: Many patients who have recently received a diagnosis of schizophrenia (e.g., "first-episode schizophrenia") respond very well to their antipsychotic medication when they are acutely ill. Once they are more stable, research has shown that first-episode patients need to remain on their antipsychotic medication. Follow-up studies show that stopping medication prematurely is the most common cause of relapse and readmission. It is important to have new ways to help patients stay stable in the community in order for them to continue on with their rehabilitation and recovery process.

Over the last decade, new antipsychotic medications have been developed that are more effective and have fewer side effects than older antipsychotics. The new medicines are often called "atypical", and were only available by pill or capsule for long-term treatment. Most recently, one of the atypical medications - risperidone - became available as a long-acting injection that can be given once every 2 weeks.

The hypothesis of this study is that patients recovering from an acute episode and who then go on to receive a long-acting version of atypical antipsychotic medication (long-acting risperidone microspheres) will stay on their medications for longer than those who take their atypical medication (any available first-line atypical) in the oral (pill) form.


Options:
A: 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
B: 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.
C: There is a 2 step inclusion/exclusion criteria, the first being for assessing overall eligibility to be enter, and then, for continued outpatient treatment for schizophrenia when clinically appropriate.

Inclusion criteria for the first phase:

1. Between 16-50 years of age
2. Psychotic symptoms must have persisted at least one month prior to starting the current antipsychotic
3. Continue to show some positive (psychotic) symptoms of schizophrenia
4. A provisional clinical diagnosis of schizophreniform disorder,schizophrenia, or schizoaffective disorder
5. Confirm that there was no previous history of significant pharmacological treatment with an antipsychotic medication
6. Able to fully participate in the informed consent process

Exclusion criteria for Study Phase I

1. Unable to understand informed consent process
2. A history of nonresponse to, or severe adverse events from, any prior exposure to oral risperidone
3. Will not be living close enough to the medical center to return for follow-up visits or assessments
4. Currently receiving medication over objection by court order

Inclusion criteria for Study Phase II

Key criteria for entry into Study Phase II are:

1. Has clinically responded to the oral antipsychotic regimen
2. Willingness to transition to receive evaluation and future pharmacologic treatment at the Schizophrenia Research Service
3. Has retained capacity to understand the risks and benefits of the maintenance treatment with antipsychotics
4. Willingness to sign informed consent to go into Study Phase II

Exclusion criteria for Study Phase II

1. Has not responded to the current oral antipsychotic regimen, or has had significant side effects to oral risperidone
2. Explicit refusal to even consider the possibility of receiving maintenance antipsychotic by long-acting injection
D: Inclusion Criteria:

* A diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated types) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) for at least 1 year before the screening evaluation
* a total PANSS score of 60 to 120 at screening and baseline (pre-treatment) evaluations
* a body mass index (BMI \[weight (kilograms)\]/\[height (meters)\]²) of at least 15.0 kg/m² .

Exclusion Criteria:

* A primary active DSM-IV Axis I diagnosis other than schizophrenia
* a decrease of 25% or more in the total PANSS score between screening and baseline evaluations
* a DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation
* a history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
* a woman who is pregnant, breast-feeding, or planning to become pregnant during the study period.

Answer: C