ID

32100

Beskrivning

An Efficacy and Safety Study of 3 Fixed Doses of JNJ-37822681 in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00728195

Länk

https://clinicaltrials.gov/show/NCT00728195

Nyckelord

Versioner (1)
  1. 2018-10-17 2018-10-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00728195

Engelsk

Eligibility Schizophrenia NCT00728195

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Beskrivning

Schizophrenia Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
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
Beskrivning

Acute exacerbation Duration PANSS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0743630
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C4086747
women of child bearing potential must have a negative urine pregnancy test at screening and baseline before receiving the study drug
Beskrivning

Childbearing Potential Urine pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
participants must agree to voluntary hospitalization for a minimum of 14 days
Beskrivning

HOSPITALIZATION VOLUNTARY Duration Minimum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0745044
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C1524031
bmi (body mass index) maximum 40 kilogram per meter square (kg/m^2), inclusive (bmi=weight/height^2)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
a dsm-iv axis i diagnosis other than schizophrenia
Beskrivning

Axis I diagnosis | Exception Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
a dsm-iv diagnosis of substance dependence within 6 months prior to screening evaluation
Beskrivning

Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0025519
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0221102
UMLS CUI [3,4]
C0013230
UMLS CUI [4]
C0010346
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0022658
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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0036572
UMLS CUI [5]
C0007820
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0021053
UMLS CUI [10,1]
C0007222
UMLS CUI [10,2]
C0443343
UMLS CUI [11,1]
C0035204
UMLS CUI [11,2]
C0443343
UMLS CUI [12,1]
C0027765
UMLS CUI [12,2]
C0443343
UMLS CUI [13,1]
C0036572
UMLS CUI [13,2]
C0443343
UMLS CUI [14,1]
C0007820
UMLS CUI [14,2]
C0443343
UMLS CUI [15,1]
C0022658
UMLS CUI [15,2]
C0443343
UMLS CUI [16,1]
C0023895
UMLS CUI [16,2]
C0443343
UMLS CUI [17,1]
C0014130
UMLS CUI [17,2]
C0443343
UMLS CUI [18,1]
C0021053
UMLS CUI [18,2]
C0443343
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)
Beskrivning

Neuroleptic Malignant Syndrome | FEVER HIGH | Muscle Rigidity | Tremor | Confusion | Increased sweating | Tachycardia | Increase in blood pressure | Myalgia | Weakness

Datatyp

boolean

Alias
UMLS CUI [1]
C0027849
UMLS CUI [2]
C0743973
UMLS CUI [3]
C0026837
UMLS CUI [4]
C0040822
UMLS CUI [5]
C0009676
UMLS CUI [6]
C0700590
UMLS CUI [7]
C0039231
UMLS CUI [8]
C0497247
UMLS CUI [9]
C0231528
UMLS CUI [10]
C3714552
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Similar models

Eligibility Schizophrenia NCT00728195

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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