ID

42748

Description

MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016); ODM derived from: https://clinicaltrials.gov/show/NCT00506077

Link

https://clinicaltrials.gov/show/NCT00506077

Keywords

Versions (2)
  1. 21/8/17 21/8/17 -
  2. 17/9/21 17/9/21 -
Uploaded on

17 de septiembre de 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Paranoid Schizophrenia NCT00506077

English

Eligibility Paranoid Schizophrenia NCT00506077

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months
Description

Stable status Clinical | Antipsychotic Agents Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0178602
patient has a 6th grade reading level or better
Description

Reading Grade Level

Data type

boolean

Alias
UMLS CUI [1,1]
C0034754
UMLS CUI [1,2]
C0870612
females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout the study
Description

Pregnancy Absent | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
patient has had a stable living arrangement for at least 3 months prior to study start
Description

Living Arrangement Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0242487
UMLS CUI [1,2]
C0205360
patient is in general good health based on screening assessments
Description

General health good

Data type

boolean

Alias
UMLS CUI [1]
C1277245
patient has total positive and negative syndrome scale (panss) score between 36 and 75 at screening and at the first baseline visit
Description

Positive and negative syndrome scale

Data type

boolean

Alias
UMLS CUI [1]
C0451383
patient has a clinical global impressions - severity (cgi-s) score less than or equal to 4 at screening and at the first baseline visit
Description

Clinical Global Impression Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3639708
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation
Description

Disease Major | Interference Testing Cognitive | Mental Retardation | Disease Major At risk Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0039593
UMLS CUI [2,3]
C1516691
UMLS CUI [3]
C0025362
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205164
UMLS CUI [4,3]
C1444641
UMLS CUI [4,4]
C2348568
patient has a history of head trauma with loss of consciousness greater than 15 minutes
Description

Craniocerebral Trauma | Unconscious State Duration

Data type

boolean

Alias
UMLS CUI [1]
C0018674
UMLS CUI [2,1]
C0041657
UMLS CUI [2,2]
C0449238
patient has had warfarin treatment, mao inhibitors, clonazepam or clozapine within 1 month of screening
Description

Warfarin | Monoamine Oxidase Inhibitors | Clonazepam | Clozapine

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0026457
UMLS CUI [3]
C0009011
UMLS CUI [4]
C0009079
patient has had ect treatment within 6 months of screening
Description

Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
patient requires treatment with antihistamines or certain other medications listed in the protocol
Description

Antihistamines Patient need for | Pharmaceutical Preparations Study Protocol Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0019590
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0686904
patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within the past 5 years
Description

Liver disease | Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0006826
patient has a history of alcohol or drug dependence within the past year or alcohol or drug abuse within 3 months of screening
Description

Substance Dependence | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
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Similar models

Eligibility Paranoid Schizophrenia NCT00506077

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Stable status Clinical | Antipsychotic Agents Dose
Item
patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Reading Grade Level
Item
patient has a 6th grade reading level or better
boolean
C0034754 (UMLS CUI [1,1])
C0870612 (UMLS CUI [1,2])
Pregnancy Absent | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods
Item
females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout the study
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Living Arrangement Stable
Item
patient has had a stable living arrangement for at least 3 months prior to study start
boolean
C0242487 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
General health good
Item
patient is in general good health based on screening assessments
boolean
C1277245 (UMLS CUI [1])
Positive and negative syndrome scale
Item
patient has total positive and negative syndrome scale (panss) score between 36 and 75 at screening and at the first baseline visit
boolean
C0451383 (UMLS CUI [1])
Clinical Global Impression Questionnaire
Item
patient has a clinical global impressions - severity (cgi-s) score less than or equal to 4 at screening and at the first baseline visit
boolean
C3639708 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Major | Interference Testing Cognitive | Mental Retardation | Disease Major At risk Study Subject Participation Status
Item
patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation
boolean
C0012634 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C1516691 (UMLS CUI [2,3])
C0025362 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
Craniocerebral Trauma | Unconscious State Duration
Item
patient has a history of head trauma with loss of consciousness greater than 15 minutes
boolean
C0018674 (UMLS CUI [1])
C0041657 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Warfarin | Monoamine Oxidase Inhibitors | Clonazepam | Clozapine
Item
patient has had warfarin treatment, mao inhibitors, clonazepam or clozapine within 1 month of screening
boolean
C0043031 (UMLS CUI [1])
C0026457 (UMLS CUI [2])
C0009011 (UMLS CUI [3])
C0009079 (UMLS CUI [4])
Electroconvulsive Therapy
Item
patient has had ect treatment within 6 months of screening
boolean
C0013806 (UMLS CUI [1])
Antihistamines Patient need for | Pharmaceutical Preparations Study Protocol Patient need for
Item
patient requires treatment with antihistamines or certain other medications listed in the protocol
boolean
C0019590 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Liver disease | Malignant Neoplasm
Item
patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within the past 5 years
boolean
C0023895 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Substance Dependence | Substance Use Disorders
Item
patient has a history of alcohol or drug dependence within the past year or alcohol or drug abuse within 3 months of screening
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
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