Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group, Comparative Study of Flexibly Dosed Paliperidone Palmitate (25, 50, 75, or 100 mg eq.) Administered Every 4 Weeks and Flexibly Dosed RISPERDAL CONSTA (25, 37.5, or 50 mg) Administered Every 2 Weeks in Subjects With Schizophrenia
Brief Summary: The purpose of this study is to compare the effectiveness and safety over 1 year of treatment of intramuscular injections of paliperidone palmitate and long-acting risperidone in patients with schizophrenia.


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: 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:

* 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.
D: 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.

Answer: C