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ID

42748

Description

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

Lien

https://clinicaltrials.gov/show/NCT00506077

Mots-clés

Versions (2)
  1. 21/08/2017 21/08/2017 -
  2. 17/09/2021 17/09/2021 -
Téléchargé le

17 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Paranoid Schizophrenia NCT00506077

    Anglais

    Eligibility Paranoid Schizophrenia NCT00506077

    1 Formulaires  
    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0038580
    UMLS CUI [2]
    C0038586
    Retour au début de la page

    Similar models

    Eligibility Paranoid Schizophrenia NCT00506077

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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