Please select the eligibility criteria that correspond to the clinical trial below.
Title: Risperidone Long Acting: A Healthcare Resource Utilization Pilot Study
Brief Summary: The primary objective of this pilot study is to evaluate the impact of switching 30 subjects from an existing antipsychotic to risperidone long acting on healthcare resource utilization. The study will be a ten month open-label, 'mirror-image', pilot study. Healthcare resource utilization during the 10 months prior to starting risperidone long acting will be retrospectively collected for all subjects (period A) at the beginning of the study. The utilization of direct medical resources will also be collected for 10 months after initiation of risperidone long acting (period B). In this design the patients will serve as their own control.


Options:
A: 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.
B: 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
C: 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.
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: D