Schizophrenia | Schizophrenia Secondary to Other medical condition | Schizophrenia Secondary to Substance Use Disorders
Item
subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
boolean
C0036341 (UMLS CUI [1])
C0036341 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C3843040 (UMLS CUI [2,3])
C0036341 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0038586 (UMLS CUI [3,3])
Hospitalization Patient need for
Item
require inpatient hospitalization.
boolean
C0019993 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Gender | Childbearing Potential Contraceptive methods
Item
woman may enroll only if they are not of child-bearing potential or are on a protocol-approved birth control method.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Schizophrenia First episode
Item
subject is in their first episode of schizophrenia.
boolean
C0036341 (UMLS CUI [1,1])
C0439615 (UMLS CUI [1,2])
Psychotic Disorders | Bipolar Disorder
Item
subject has other psychotic disorders or bipolar disorder.
boolean
C0033975 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
Schizophrenia Symptoms Due to Pharmaceutical Preparations | Schizophrenia Symptoms Due to Drug abuse | Schizophrenia Symptoms Due to medical condition
Item
subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
boolean
C0036341 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0036341 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0013146 (UMLS CUI [2,4])
C0036341 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C3843040 (UMLS CUI [3,4])
Substance Dependence | Dependence | Illicit Drugs Test Positive
Item
subject has a recent history of substance dependence/dependence, or tests positive for illicit drug.
boolean
C0038580 (UMLS CUI [1])
C0439857 (UMLS CUI [2])
C0086190 (UMLS CUI [3,1])
C0456984 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Disease Unstable | Disease Significant | Autistic Disorder | Organic brain disorder | Liver Dysfunction | Epilepsy | Seizures | Cerebrovascular Disorders Risk Increased | Cerebrovascular accident
Item
subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0004352 (UMLS CUI [3])
C4062280 (UMLS CUI [4])
C0086565 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0036572 (UMLS CUI [7])
C0007820 (UMLS CUI [8,1])
C0035647 (UMLS CUI [8,2])
C0205217 (UMLS CUI [8,3])
C0038454 (UMLS CUI [9])
Abnormality Significant Screening test | Electrocardiography | Laboratory Procedures | Physical Examination
Item
subject has any significant abnormalities in any of the screening tests (ecgs, labs, physical examinations, etc.).
boolean
C1704258 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0871311 (UMLS CUI [1,3])
C1623258 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
At risk for suicide Serious | Homicide Risk Serious
Item
subject poses a current serious suicidal or homicidal risk.
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019872 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Pregnancy test positive | Breast Feeding | Pregnancy, Planned
Item
subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study.
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status
Item
subject has recently or is currently participating in another clinical study.
boolean
C2348568 (UMLS CUI [1])
Therapeutic procedure Stabilized Schizophrenia
Item
subject is stabilized on their current schizophrenia treatment.
boolean
C0087111 (UMLS CUI [1,1])
C0184512 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Pharmaceutical Preparations Illicit Patient need for | Electroconvulsive Therapy | Transcranial magnetic stimulation
Item
subject needs to take any of the medicines not permitted in the study, or has recently had ect (electroconvulsive therapy) or tms (transcranial magnetic stimulation).
boolean
C0013227 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0013806 (UMLS CUI [2])
C0436548 (UMLS CUI [3])
Antipsychotic drug therapy Quantity Poor response to treatment
Item
subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years.
boolean
C1319421 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [1,3])
Allergic Reaction Investigational New Drugs | Reaction Significant Investigational New Drugs | Risperidone Intake Unable
Item
subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0443286 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0073393 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])