ID

19366

Description

A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00573417

Link

https://clinicaltrials.gov/show/NCT00573417

Keywords

Versions (1)
  1. 12/22/16 12/22/16 -
Uploaded on

December 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00573417

English

Eligibility Schizophrenia NCT00573417

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of schizophrenia, any subtype or schizoaffective disorder
Description

Schizophrenia Subtype Any | Schizoaffective Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0449560
UMLS CUI [1,3]
C1552551
UMLS CUI [2]
C0036337
ages 18-65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
capable of providing informed consent, or capable of providing assent with a guardian who provides informed consent
Description

Informed Consent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
stable dose of clozapine for at least 1 month
Description

Clozapine Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0009079
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
three months of stable psychotic symptoms
Description

Psychotic symptoms Stable Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
Description

Illness Serious | Nervous system disorder Serious | Heart Disease Unstable | Epilepsy | Malignant Neoplasms | Hepatic Insufficiency | Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [4]
C0014544
UMLS CUI [5]
C0006826
UMLS CUI [6]
C1306571
UMLS CUI [7]
C1565489
current substance abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
unable to complete neuropsychological tests
Description

Neuropsychological Tests Completion Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0027902
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0558080
history of serious blood dyscrasia requiring discontinuation of clozapine
Description

Hematological Disease Serious | Clozapine Discontinuation Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009079
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0686904
serious suicidal or homicidal risk within the past six months
Description

At risk for suicide Serious | Homicide At risk Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0019872
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0205404
current treatment with a psychostimulant
Description

Psychostimulant

Data type

boolean

Alias
UMLS CUI [1]
C0304403
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Similar models

Eligibility Schizophrenia NCT00573417

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia Subtype Any | Schizoaffective Disorder
Item
diagnosis of schizophrenia, any subtype or schizoaffective disorder
boolean
C0036341 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0036337 (UMLS CUI [2])
Age
Item
ages 18-65 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Guardian
Item
capable of providing informed consent, or capable of providing assent with a guardian who provides informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Clozapine Dose Stable
Item
stable dose of clozapine for at least 1 month
boolean
C0009079 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Psychotic symptoms Stable Duration
Item
three months of stable psychotic symptoms
boolean
C0871189 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Illness Serious | Nervous system disorder Serious | Heart Disease Unstable | Epilepsy | Malignant Neoplasms | Hepatic Insufficiency | Renal Insufficiency
Item
serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0014544 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C1306571 (UMLS CUI [6])
C1565489 (UMLS CUI [7])
Substance Use Disorders
Item
current substance abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling
Item
pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Neuropsychological Tests Completion Unwilling
Item
unable to complete neuropsychological tests
boolean
C0027902 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Hematological Disease Serious | Clozapine Discontinuation Patient need for
Item
history of serious blood dyscrasia requiring discontinuation of clozapine
boolean
C0018939 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009079 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
At risk for suicide Serious | Homicide At risk Serious
Item
serious suicidal or homicidal risk within the past six months
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019872 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Psychostimulant
Item
current treatment with a psychostimulant
boolean
C0304403 (UMLS CUI [1])
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