Schizophrenia
Item
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
boolean
C0036341 (UMLS CUI [1])
Medical Records Consistent with Schizophrenia | Documentation Consistent with Schizophrenia | Verbal information Consistent with Schizophrenia
Item
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
boolean
C0025102 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
C0175636 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0036341 (UMLS CUI [2,3])
C1549471 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0036341 (UMLS CUI [3,3])
PANSS | Body mass index
Item
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
boolean
C4086747 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
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.
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])
C3831118 (UMLS CUI [5,1])
C0430060 (UMLS CUI [5,2])
C1513916 (UMLS CUI [5,3])
Informed Consent Unable | Psychiatric hospitalization Involuntary | Axis I diagnosis Primary | Exception Schizophrenia
Item
patient unable to provide consent or involuntarily committed to psychiatric hospitalization; a primary, active dsm-iv diagnosis on axis i other than schizophrenia
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0748061 (UMLS CUI [2,1])
C2986385 (UMLS CUI [2,2])
C0270287 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0036341 (UMLS CUI [4,2])
Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence
Item
a dsm-iv diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0028043 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1386553 (UMLS CUI [3,2])
Treatment-resistant schizophrenia | Antipsychotic Agents Different Quantity | Antipsychotic Agents Maximum Tolerated Dose | Response failed
Item
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)
boolean
C3544321 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0040615 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C1704632 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
Cardiovascular Diseases | Respiration Disorders | Nervous system disorder | Seizures | Cerebrovascular Disorders | Kidney Diseases | Liver diseases | Hematological Disease | Endocrine System Diseases | Immune System Diseases | Systemic disease | Cardiovascular Diseases Unstable | Respiration Disorders Unstable | Nervous system disorder Unstable | Seizures Unstable | Cerebrovascular Disorders Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable | Systemic disease Unstable | Neuroleptic Malignant Syndrome | Gastrointestinal stenosis Severe Pre-existing | Lacking Able to swallow Oral medication
Item
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)
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])
C0018939 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0021053 (UMLS CUI [10])
C0442893 (UMLS CUI [11])
C0007222 (UMLS CUI [12,1])
C0443343 (UMLS CUI [12,2])
C0035204 (UMLS CUI [13,1])
C0443343 (UMLS CUI [13,2])
C0027765 (UMLS CUI [14,1])
C0443343 (UMLS CUI [14,2])
C0036572 (UMLS CUI [15,1])
C0443343 (UMLS CUI [15,2])
C0007820 (UMLS CUI [16,1])
C0443343 (UMLS CUI [16,2])
C0022658 (UMLS CUI [17,1])
C0443343 (UMLS CUI [17,2])
C0023895 (UMLS CUI [18,1])
C0443343 (UMLS CUI [18,2])
C0018939 (UMLS CUI [19,1])
C0443343 (UMLS CUI [19,2])
C0014130 (UMLS CUI [20,1])
C0443343 (UMLS CUI [20,2])
C0021053 (UMLS CUI [21,1])
C0443343 (UMLS CUI [21,2])
C0442893 (UMLS CUI [22,1])
C0443343 (UMLS CUI [22,2])
C0027849 (UMLS CUI [23])
C0521587 (UMLS CUI [24,1])
C0205082 (UMLS CUI [24,2])
C2347662 (UMLS CUI [24,3])
C0332268 (UMLS CUI [25,1])
C2712086 (UMLS CUI [25,2])
C0175795 (UMLS CUI [25,3])
At risk for suicide | At risk Physical aggression | Drug Allergy Life Threatening | Risperidone allergy | Hypersensitivity Paliperidone | Hypersensitivity Intralipid Percentage | Intolerance to Risperidone | Intolerance to Paliperidone | Intolerance to Intralipid Percentage | Hypersensitivity Soybean Oil | Allergy to egg yolks | Hypersensitivity Phospholipids | Glycerol allergy | Intolerance to Soybean Oil | Intolerance to Egg Yolks | Intolerance to Phospholipids | Intolerance to Glycerol
Item
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)
boolean
C0563664 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0424323 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
C0570837 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0753678 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0733854 (UMLS CUI [6,2])
C0439165 (UMLS CUI [6,3])
C1744706 (UMLS CUI [7,1])
C0073393 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0753678 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C0733854 (UMLS CUI [9,2])
C0439165 (UMLS CUI [9,3])
C0020517 (UMLS CUI [10,1])
C0037732 (UMLS CUI [10,2])
C3468092 (UMLS CUI [11])
C0020517 (UMLS CUI [12,1])
C0031676 (UMLS CUI [12,2])
C0571234 (UMLS CUI [13])
C1744706 (UMLS CUI [14,1])
C0037732 (UMLS CUI [14,2])
C1744706 (UMLS CUI [15,1])
C0013707 (UMLS CUI [15,2])
C1744706 (UMLS CUI [16,1])
C0031676 (UMLS CUI [16,2])
C1744706 (UMLS CUI [17,1])
C0017861 (UMLS CUI [17,2])
Investigational New Drugs | Biological agents Investigational | Investigational Medical Device | Malignant Neoplasms | Exception Basal cell carcinoma
Item
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
boolean
C0013230 (UMLS CUI [1])
C0005515 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant or breast-feeding or are planning to become pregnant uring the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])