Informed Consent | Informed Consent Patient Representatives
Item
subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as require by irb/iec), prior to the initiation of any protocol-required procedures.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Age
Item
male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Clinical Trials Specified Completed | Patient withdrawn from trial specified | Study Subject New | Participation Absent Clinical Trials Specified
Item
subjects who complete studies 246/247 or who withdrew from the double-blind maintenance phase of either study (phase 4 of study 246 or phase 3 of study 247), or new subjects not participating in studies 246/247.
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0422727 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0681850 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0679823 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
C0205369 (UMLS CUI [4,4])
Patient need for Antipsychotic Agents chronic
Item
# subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
boolean
C0686904 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Comprehension Study Protocol | Protocol Compliance | Depot Preparations Intramuscular injection | Illicit Drugs Discontinuation | Rating scale Assessment
Item
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.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C0086129 (UMLS CUI [3,1])
C0021492 (UMLS CUI [3,2])
C0086190 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0681889 (UMLS CUI [5,1])
C1516048 (UMLS CUI [5,2])
Mental disorders | Exception Schizophrenia | Schizoaffective Disorder | Major Depressive Disorder | Bipolar Disorder | Delirium | Dementia | Amnestic Disorder | Cognition Disorders | Borderline Personality Disorder | Paranoid Personality Disorder | Histrionic Personality Disorder | Schizotypal Personality Disorder | Schizoid Personality Disorder | Antisocial Personality Disorder
Item
subjects with a current dsm-iv-tr diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
boolean
C0004936 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C0036337 (UMLS CUI [3])
C1269683 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0011206 (UMLS CUI [6])
C0497327 (UMLS CUI [7])
C0002625 (UMLS CUI [8])
C0009241 (UMLS CUI [9])
C0006012 (UMLS CUI [10])
C0030477 (UMLS CUI [11])
C0019681 (UMLS CUI [12])
C0036363 (UMLS CUI [13])
C0036339 (UMLS CUI [14])
C0003431 (UMLS CUI [15])
Schizophrenia Resistant to Antipsychotic Agents | Schizophrenia Antipsychotic Agents Refractory | Clozapine Response
Item
subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
boolean
C0036341 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0040615 (UMLS CUI [1,3])
C0036341 (UMLS CUI [2,1])
C0040615 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0009079 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
At risk Violent behavior | At risk for suicide
Item
subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
boolean
C1444641 (UMLS CUI [1,1])
C0424323 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2])
Substance Dependence | Benzodiazepines | Exception Caffeine dependence | Exception Nicotine Dependence | DRUG SCREEN COCAINE POSITIVE Quantity
Item
subjects who currently meet dsm-iv-tr criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine.
boolean
C0038580 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1386553 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0028043 (UMLS CUI [4,2])
C0743294 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Hypersensitivity Aripiprazole | Intolerance to Aripiprazole | Aripiprazole Unresponsive to Treatment | Hypersensitivity Quinolones | Intolerance to Quinolones | Quinolones Unresponsive to Treatment
Item
subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
boolean
C0020517 (UMLS CUI [1,1])
C0299792 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0299792 (UMLS CUI [2,2])
C0299792 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0034428 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0034428 (UMLS CUI [5,2])
C0034428 (UMLS CUI [6,1])
C0205269 (UMLS CUI [6,2])
Hypersensitivity Antipsychotic Agents
Item
subjects with a history of hypersensitivity to antipsychotic agents.
boolean
C0020517 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
Neuroleptic Malignant Syndrome | Tardive Dyskinesia
Item
subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
boolean
C0027849 (UMLS CUI [1])
C0686347 (UMLS CUI [2])