Schizophrenia Disease length
Item
participants must have been diagnosed with schizophrenia according to diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to screening
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Acute exacerbation Duration PANSS
Item
participants must be experiencing an acute (a quick and severe form of illness in its early stage) exacerbation of less than 6 months duration, with a positive and negative syndrome scale (panss) total score at screening between 70 and 120 inclusive and at baseline of between 60 and 120 inclusive
boolean
C0743630 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Childbearing Potential Urine pregnancy test negative
Item
women of child bearing potential must have a negative urine pregnancy test at screening and baseline before receiving the study drug
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
HOSPITALIZATION VOLUNTARY Duration Minimum
Item
participants must agree to voluntary hospitalization for a minimum of 14 days
boolean
C0745044 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Body mass index
Item
bmi (body mass index) maximum 40 kilogram per meter square (kg/m^2), inclusive (bmi=weight/height^2)
boolean
C1305855 (UMLS CUI [1])
Axis I diagnosis | Exception Schizophrenia
Item
a dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Substance Dependence
Item
a dsm-iv diagnosis of substance dependence within 6 months prior to screening evaluation
boolean
C0038580 (UMLS CUI [1])
Medical condition Changing Absorption Investigational New Drugs | Medical condition Changing Metabolism Investigational New Drugs | Medical condition Changing Excretion Investigational New Drugs | Crohn Disease | Liver diseases | Kidney Diseases
Item
any clinically relevant medical condition that could potentially alter the absorption (the way a drug or other substance enters the body), metabolism, or excretion (the way that substances leave the body) of the study medication, such as crohn's disease (serious inflammation of any part of the gastrointestinal tract), liver disease, or renal (pertaining to the kidneys) disease
boolean
C3843040 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0025519 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0221102 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0010346 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
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
Item
relevant history of any significant and/or unstable cardiovascular (pertaining to the heart and blood vessels), respiratory, neurological (including seizures) or significant cerebrovascular (pertaining to brain and blood vessels), renal, hepatic, endocrine (pertaining to the glands that make hormones), or immunologic diseases
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])
Neuroleptic Malignant Syndrome | FEVER HIGH | Muscle Rigidity | Tremor | Confusion | Increased sweating | Tachycardia | Increase in blood pressure | Myalgia | Weakness
Item
history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
boolean
C0027849 (UMLS CUI [1])
C0743973 (UMLS CUI [2])
C0026837 (UMLS CUI [3])
C0040822 (UMLS CUI [4])
C0009676 (UMLS CUI [5])
C0700590 (UMLS CUI [6])
C0039231 (UMLS CUI [7])
C0497247 (UMLS CUI [8])
C0231528 (UMLS CUI [9])
C3714552 (UMLS CUI [10])