Schizophrenia
Item
meets the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria for schizophrenia
boolean
C0036341 (UMLS CUI [1])
Acute schizophrenic episode PANSS
Item
must be experiencing an acute schizophrenic episode with a positive and negative syndrome scale (panss) total score of greater than or equal to 70 at baseline
boolean
C0813173 (UMLS CUI [1,1])
C4086747 (UMLS CUI [1,2])
Hospital admission Acute schizophrenic episode | HOSPITALIZATION VOLUNTARY Duration
Item
must be admitted to hospital for treatment of the acute schizophrenic episode and must agree for voluntary hospitalization for at least the first 7 days of the study
boolean
C0184666 (UMLS CUI [1,1])
C0813173 (UMLS CUI [1,2])
C0745044 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Prescription Oral Contraceptives | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch | Partner had vasectomy | Childbearing Potential Urine pregnancy test negative
Item
female participants must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study and female participants of child-bearing potential must have a negative urine pregnancy test at screening
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C0033080 (UMLS CUI [5,1])
C0009905 (UMLS CUI [5,2])
C1656586 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C2985284 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
C3831118 (UMLS CUI [11,1])
C0430057 (UMLS CUI [11,2])
Informed Consent | Informed Consent Patient Representatives
Item
participants or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding female participants
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Antipsychotic drug therapy First
Item
first antipsychotic treatment ever
boolean
C1319421 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
Investigational New Drugs | Investigational Medical Device | Clozapine | Antipsychotic Agent Injectable Active Long-term
Item
have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment and on clozapine or a long-acting injectable antipsychotic during the last 3 months
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0009079 (UMLS CUI [3])
C0040615 (UMLS CUI [4,1])
C0086466 (UMLS CUI [4,2])
C0205177 (UMLS CUI [4,3])
C0443252 (UMLS CUI [4,4])
Hypersensitivity Paliperidone ER | Risperidone allergy
Item
known hypersensitivity to paliperidone extended-release (er) or risperidone
boolean
C0020517 (UMLS CUI [1,1])
C4058551 (UMLS CUI [1,2])
C0570837 (UMLS CUI [2])
Cardiovascular Diseases | Respiration Disorders | Nervous system disorder | Seizures | Cerebrovascular Disorders | Kidney Diseases | Liver diseases | Endocrine System Diseases | Immune System Diseases | Cardiovascular Diseases Unstable | Respiration Disorders Unstable | Nervous system disorder Unstable | Seizures Unstable | Cerebrovascular Disorders Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable | Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Neuroleptic Malignant Syndrome | Laboratory test result abnormal | Substance Dependence
Item
relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome including recent or present clinically relevant laboratory abnormalities (as deemed by the investigator) and participants with current or known history (over the past 6 months) of substance dependence according to dsm-iv criteria
boolean
C0007222 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0036572 (UMLS CUI [4])
C0007820 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0021053 (UMLS CUI [9])
C0007222 (UMLS CUI [10,1])
C0443343 (UMLS CUI [10,2])
C0035204 (UMLS CUI [11,1])
C0443343 (UMLS CUI [11,2])
C0027765 (UMLS CUI [12,1])
C0443343 (UMLS CUI [12,2])
C0036572 (UMLS CUI [13,1])
C0443343 (UMLS CUI [13,2])
C0007820 (UMLS CUI [14,1])
C0443343 (UMLS CUI [14,2])
C0022658 (UMLS CUI [15,1])
C0443343 (UMLS CUI [15,2])
C0023895 (UMLS CUI [16,1])
C0443343 (UMLS CUI [16,2])
C0014130 (UMLS CUI [17,1])
C0443343 (UMLS CUI [17,2])
C0021053 (UMLS CUI [18,1])
C0443343 (UMLS CUI [18,2])
C0686347 (UMLS CUI [19])
C1457887 (UMLS CUI [20,1])
C0686347 (UMLS CUI [20,2])
C0027849 (UMLS CUI [21])
C0438215 (UMLS CUI [22])
C0038580 (UMLS CUI [23])