Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia
Brief Summary: Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.


Options:
A: Inclusion Criteria:

* Patients age 18 years or older to less than 65 years, inclusive (at time of informed consent)
* Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening (as per subject, family, healthcare provider, or by previous medical records).
* Subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
* Subjects who showed previous response to antipsychotic treatment in the past year.
* Subjects who are currently treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic treatment with antipsychotic medication for stabilization.
* Subjects who are experiencing a current acute exacerbation of psychotic symptoms requiring stabilization
* Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

Exclusion Criteria:

* Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
* Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
* Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
* Subjects experiencing acute depressive symptoms within the past 30 days
* Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history
* Subjects with a significant risk of violent behavior; who represent a risk of committing suicide
* Subjects with clinically significant tardive dyskinesia
* Subjects currently treated with insulin for diabetes.
B: 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
C: Inclusion Criteria:

* Participants who have provided informed consent prior to any study specific procedures.
* Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.
* Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
* Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
* Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
* Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
* Body mass index between 18 and 40 kg/m\^2, inclusive.

Exclusion Criteria:

* Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
* Participants in their first episode of psychosis.
* Treatment-resistant schizophrenia over the last 2 years.
* Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
* At imminent risk of injuring self or others or causing significant damage to property.
* Suicide risk.
D: Key Inclusion Criteria:

* Have a primary diagnosis of schizophrenia
* History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening
* History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening
* Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms

Key Exclusion Criteria:

* Have an uncontrolled, unstable clinically significant medical condition
* History of suicide attempt or significant violence to others in the past 2 years
* A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
* Current substance abuse/dependence
* Concurrent psychiatric disorder other than schizophrenia.

Answer: D