ID

32308

Description

A Pharmacokinetics Study to Evaluate Safety and Tolerability of JNJ-37822681 in Participants With Stable Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01812642

Link

https://clinicaltrials.gov/show/NCT01812642

Keywords

Versions (1)
  1. 10/26/18 10/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 26, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01812642

English

Eligibility Schizophrenia NCT01812642

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have schizophrenia diagnosis by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv)
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
known history of schizophrenia of at least 12 months by the referring psychiatrist
Description

Schizophrenia Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
positive and negative syndrome scale score at screening less than 70
Description

PANSS

Data type

boolean

Alias
UMLS CUI [1]
C4086747
body mass index (bmi) between 18 and 35 kilogram divided by square meter inclusive (bmi =weight per square height)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
female participants must meet any one of the following: postmenopausal (amenorrhea for at least 12 months and follicle stimulating hormone levels of greater than 40 milli-international unit (miu ) per milliliter at screening), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation or otherwise be incapable of pregnancy)
Description

Postmenopausal state | Amenorrhea Duration | Follicle stimulating hormone measurement | Female Sterilization | Hysterectomy | Bilateral oophorectomy | Tubal Ligation | Gender Infertility

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0202022
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0020699
UMLS CUI [6]
C0278321
UMLS CUI [7]
C0520483
UMLS CUI [8,1]
C0079399
UMLS CUI [8,2]
C0021359
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any medical condition that could potentially alter the absorption, metabolism or excretion of the study medication, such as crohn's (serious inflammation of any part of the gastrointestinal tract) disease, liver disease, or renal disease
Description

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

Data type

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, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine or immunologic diseases
Description

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

Data type

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
Description

Neuroleptic Malignant Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0027849
female participants of childbearing potential
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
significant risk of suicidal or violent behavior
Description

At risk Suicidal behavior | At risk Physical aggression

Data type

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C1760428
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0424323
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Similar models

Eligibility Schizophrenia NCT01812642

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
have schizophrenia diagnosis by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv)
boolean
C0036341 (UMLS CUI [1])
Schizophrenia Disease length
Item
known history of schizophrenia of at least 12 months by the referring psychiatrist
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
PANSS
Item
positive and negative syndrome scale score at screening less than 70
boolean
C4086747 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 18 and 35 kilogram divided by square meter inclusive (bmi =weight per square height)
boolean
C1305855 (UMLS CUI [1])
Postmenopausal state | Amenorrhea Duration | Follicle stimulating hormone measurement | Female Sterilization | Hysterectomy | Bilateral oophorectomy | Tubal Ligation | Gender Infertility
Item
female participants must meet any one of the following: postmenopausal (amenorrhea for at least 12 months and follicle stimulating hormone levels of greater than 40 milli-international unit (miu ) per milliliter at screening), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation or otherwise be incapable of pregnancy)
boolean
C0232970 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0202022 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0278321 (UMLS CUI [6])
C0520483 (UMLS CUI [7])
C0079399 (UMLS CUI [8,1])
C0021359 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
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 medical condition that could potentially alter the absorption, metabolism or excretion of the study medication, such as crohn's (serious inflammation of any part of the gastrointestinal tract) disease, liver disease, or renal 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, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine 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
Item
history of neuroleptic malignant syndrome
boolean
C0027849 (UMLS CUI [1])
Childbearing Potential
Item
female participants of childbearing potential
boolean
C3831118 (UMLS CUI [1])
At risk Suicidal behavior | At risk Physical aggression
Item
significant risk of suicidal or violent behavior
boolean
C1444641 (UMLS CUI [1,1])
C1760428 (UMLS CUI [1,2])
C1444641 (UMLS CUI [2,1])
C0424323 (UMLS CUI [2,2])
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