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 required by institutional review board/independent ethics committee [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 60 years of age, inclusive, at time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia Disease length
Item
subjects with a current diagnosis of schizophrenia as defined by diagnostic and statistical manual of mental disorders, version 4, text revision (dsm-iv-tr) criteria and a history of the illness for at least 3 years prior to screening.
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Patient need for Antipsychotic Agents chronic
Item
subjects who, in the investigator's judgment, require chronic treatment with an anti-psychotic 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 outcome 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 2 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 | Hypersensitivity Antipsychotic Agents
Item
subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones, or hypersensitivity to anti-psychotic agents, including aripiprazole.
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])
C0020517 (UMLS CUI [7,1])
C0040615 (UMLS CUI [7,2])
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])
Abnormal thyroid function Uncontrolled
Item
subjects with uncontrolled thyroid function abnormalities.
boolean
C0857576 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Seizures | Neuroleptic Malignant Syndrome | Tardive Dyskinesia | Other medical condition At risk Patients | Other medical condition Interferes with Evaluation
Item
subjects with a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose the subject to undue risk or interfere with study assessments.
boolean
C0036572 (UMLS CUI [1])
C0027849 (UMLS CUI [2])
C0686347 (UMLS CUI [3])
C3843040 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0030705 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
Incarcerated Involuntary
Item
subjects who are involuntarily incarcerated.
boolean
C0392751 (UMLS CUI [1,1])
C2986385 (UMLS CUI [1,2])
Electroconvulsive Therapy
Item
subjects who have undergone electroconvulsive therapy within 180 days of entry into phase 2.
boolean
C0013806 (UMLS CUI [1])
Investigational New Drugs | Study Subject Participation Status | Aripiprazole Depot Preparation Intramuscular injection
Item
subjects who have used an investigational agent within 30 days of screening; and prior participation in a clinical study with aripiprazole im depot.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0299792 (UMLS CUI [3,1])
C0086129 (UMLS CUI [3,2])
C0021492 (UMLS CUI [3,3])
Laboratory test result abnormal | Abnormal vital signs | ECG abnormal
Item
subjects with clinically significant abnormalities in laboratory test results, vital signs, or ecg results.
boolean
C0438215 (UMLS CUI [1])
C0277804 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
Hospital stay duration
Item
subjects hospitalized for more than 30 days in the 90 days prior to phase 1 (or phase 2 for subjects bypassing phase 1).
boolean
C4019086 (UMLS CUI [1])
Benzodiazepines Quantity | Lorazepam | Oxazepam
Item
subjects requiring more than 1 benzodiazepine beyond screening (eg, lorazepam and oxazepam).
boolean
C0005064 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0024002 (UMLS CUI [2])
C0029997 (UMLS CUI [3])
Illicit Drugs Washout failed | CYP2D6 Inhibitors | CYP3A4 Inhibitors | CYP3A4 Inducers | Antipsychotic Agents | Antidepressive Agents | Monoamine Oxidase Inhibitors | Mood Stabilizers
Item
subjects who fail to wash-out from prohibited concomitant medications, including the use of cyp2d6 or cyp3a4 inhibitors or cyp3a4 inducers, antipsychotics, antidepressants (including monoamine oxidase inhibitors [maoi]), and mood stabilizers, during screening and phase 1.
boolean
C0086190 (UMLS CUI [1,1])
C1710661 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C3850058 (UMLS CUI [2])
C3850053 (UMLS CUI [3])
C3850041 (UMLS CUI [4])
C0040615 (UMLS CUI [5])
C0003289 (UMLS CUI [6])
C0026457 (UMLS CUI [7])
C4020582 (UMLS CUI [8])