0 Évaluations

ID

15044

Description

A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02286440

Lien

https://clinicaltrials.gov/show/NCT02286440

Mots-clés

  1. 12/05/2016 12/05/2016 -
Téléchargé le

12 mai 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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    Eligibility Depression NCT02286440

    Eligibility Depression NCT02286440

    1. StudyEvent: Eligibility
      1. Eligibility Depression NCT02286440
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    age 13-18, male or female, any race/ethnicity
    Description

    Age | Racial group | Ethnic group

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    UMLS CUI [2]
    C0034510 (Racial group)
    SNOMED
    415229000
    LOINC
    LP7528-5
    UMLS CUI [3]
    C0015031 (Ethnic group)
    SNOMED
    398089004
    LOINC
    LP36231-6
    treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
    Description

    Indication Pharmacotherapy Part of Comprehensive treatment program

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C0013216 (Pharmacotherapy)
    SNOMED
    416608005
    UMLS CUI [1,3]
    C1292711 (part of)
    UMLS CUI [1,4]
    C0814471 (comprehensive treatment program)
    major depressive episode diagnosis or bipolar disorder based on ksads-pl semi-structured psychiatric interview with a severity criteria-40 or greater on childhood depression rating scale-revised (cdrs-r)
    Description

    Single major depressive episode | Bipolar Disorder | Severity Criteria Childhood depression Rating scale

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0024517 (Major depression, single episode)
    SNOMED
    36923009
    UMLS CUI [2]
    C0005586 (Bipolar Disorder)
    SNOMED
    13746004
    LOINC
    MTHU026189
    UMLS CUI [3,1]
    C3897634 (Severity Criteria)
    UMLS CUI [3,2]
    C2363919 (Childhood depression)
    UMLS CUI [3,3]
    C0681889 (rating scale)
    ability to provide informed consent
    Description

    Informed Consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    inability to speak english
    Description

    Able to speak English Language

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0564215 (Able to speak)
    SNOMED
    286368006
    UMLS CUI [1,2]
    C0376245 (English Language)
    SNOMED
    297487008
    LOINC
    LA43-5
    inability or lack of willingness to provide informed consent and assent.
    Description

    Unable Informed Consent

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    axis i diagnoses: autism spectrum disorder, anorexia nervosa, schizophreniform, and schizophrenia.
    Description

    Axis I diagnosis | Autism Spectrum Disorders | Anorexia Nervosa | Schizophreniform Disorders | Schizophrenia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0270287 (Axis I diagnosis)
    SNOMED
    899001
    UMLS CUI [2]
    C1510586 (Autism Spectrum Disorders)
    UMLS CUI [3]
    C0003125 (Anorexia Nervosa)
    SNOMED
    56882008
    UMLS CUI [4]
    C0036358 (Schizophreniform Disorders)
    SNOMED
    88975006
    UMLS CUI [5]
    C0036341 (Schizophrenia)
    SNOMED
    58214004
    LOINC
    MTHU020814
    psychotropic medication change (including dosage) between screening & randomization visits.
    Description

    Psychotropic Drugs Change of medication | Psychotropic Drugs Medication dose changed | Screening procedure | Randomization

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0033978 (Psychotropic Drugs)
    SNOMED
    418183005
    UMLS CUI [1,2]
    C0580105 (Change of medication)
    SNOMED
    182838006
    UMLS CUI [2,1]
    C0033978 (Psychotropic Drugs)
    SNOMED
    418183005
    UMLS CUI [2,2]
    C1608430 (Medication dose changed)
    SNOMED
    432751000124106
    UMLS CUI [3]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [4]
    C0034656 (Randomization)
    patients who meet dsm 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. must have at least early, partial or full, remission x 3 months
    Description

    Diagnostic and Statistical Manual of Mental Disorders criteria | Substance Use Disorders | Nicotine | Caffeine | Cannabis substance | Disease remission

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1136324 (Diagnostic and Statistical Manual of Mental Disorders)
    UMLS CUI [1,2]
    C0243161 (criteria)
    UMLS CUI [2]
    C0038586 (Substance Use Disorders)
    UMLS CUI [3]
    C0028040 (nicotine)
    SNOMED
    323283001
    UMLS CUI [4]
    C0006644 (caffeine)
    SNOMED
    91107009
    UMLS CUI [5]
    C0678449 (Cannabis substance)
    SNOMED
    398705004
    UMLS CUI [6]
    C0544452 (Disease remission)
    SNOMED
    277022003
    LOINC
    LA28783-1
    serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.
    Description

    At risk for suicide | Needs Hospitalization

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0563664 (At risk for suicide)
    SNOMED
    3161000175102
    LOINC
    LP36302-5
    UMLS CUI [2,1]
    C0027552 (Needs)
    SNOMED
    410525008
    UMLS CUI [2,2]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    significant unstable medical condition.
    Description

    medical condition Unstable status

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1699700 (medical condition category)
    UMLS CUI [1,2]
    C0443343 (Unstable status)
    SNOMED
    263922001
    LOINC
    LP28572-3
    anticipated inability to attend scheduled study visits.
    Description

    Unable Visit Study

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
    UMLS CUI [1,2]
    C0545082 (Visit)
    UMLS CUI [1,3]
    C2603343 (Study)
    patients who in the judgment of the investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol.
    Description

    Compliance behavior Limited

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    cytochrome (cyp) & serotonin transporter genomic testing within 5 years.
    Description

    Cytochrome | Serotonin transporter | Genome Testing

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0010798 (Cytochromes)
    UMLS CUI [2]
    C0170657 (serotonin transporter)
    UMLS CUI [3,1]
    C0017428 (Genome)
    SNOMED
    18470003
    LOINC
    LP70575-3
    UMLS CUI [3,2]
    C0039593 (Testing)

    Similar models

    Eligibility Depression NCT02286440

    1. StudyEvent: Eligibility
      1. Eligibility Depression NCT02286440
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Racial group | Ethnic group
    Item
    age 13-18, male or female, any race/ethnicity
    boolean
    C0001779 (UMLS CUI [1])
    C0034510 (UMLS CUI [2])
    C0015031 (UMLS CUI [3])
    Indication Pharmacotherapy Part of Comprehensive treatment program
    Item
    treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
    boolean
    C3146298 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    C1292711 (UMLS CUI [1,3])
    C0814471 (UMLS CUI [1,4])
    Single major depressive episode | Bipolar Disorder | Severity Criteria Childhood depression Rating scale
    Item
    major depressive episode diagnosis or bipolar disorder based on ksads-pl semi-structured psychiatric interview with a severity criteria-40 or greater on childhood depression rating scale-revised (cdrs-r)
    boolean
    C0024517 (UMLS CUI [1])
    C0005586 (UMLS CUI [2])
    C3897634 (UMLS CUI [3,1])
    C2363919 (UMLS CUI [3,2])
    C0681889 (UMLS CUI [3,3])
    Informed Consent
    Item
    ability to provide informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Able to speak English Language
    Item
    inability to speak english
    boolean
    C0564215 (UMLS CUI [1,1])
    C0376245 (UMLS CUI [1,2])
    Unable Informed Consent
    Item
    inability or lack of willingness to provide informed consent and assent.
    boolean
    C1299582 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    Axis I diagnosis | Autism Spectrum Disorders | Anorexia Nervosa | Schizophreniform Disorders | Schizophrenia
    Item
    axis i diagnoses: autism spectrum disorder, anorexia nervosa, schizophreniform, and schizophrenia.
    boolean
    C0270287 (UMLS CUI [1])
    C1510586 (UMLS CUI [2])
    C0003125 (UMLS CUI [3])
    C0036358 (UMLS CUI [4])
    C0036341 (UMLS CUI [5])
    Psychotropic Drugs Change of medication | Psychotropic Drugs Medication dose changed | Screening procedure | Randomization
    Item
    psychotropic medication change (including dosage) between screening & randomization visits.
    boolean
    C0033978 (UMLS CUI [1,1])
    C0580105 (UMLS CUI [1,2])
    C0033978 (UMLS CUI [2,1])
    C1608430 (UMLS CUI [2,2])
    C0220908 (UMLS CUI [3])
    C0034656 (UMLS CUI [4])
    Diagnostic and Statistical Manual of Mental Disorders criteria | Substance Use Disorders | Nicotine | Caffeine | Cannabis substance | Disease remission
    Item
    patients who meet dsm 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. must have at least early, partial or full, remission x 3 months
    boolean
    C1136324 (UMLS CUI [1,1])
    C0243161 (UMLS CUI [1,2])
    C0038586 (UMLS CUI [2])
    C0028040 (UMLS CUI [3])
    C0006644 (UMLS CUI [4])
    C0678449 (UMLS CUI [5])
    C0544452 (UMLS CUI [6])
    At risk for suicide | Needs Hospitalization
    Item
    serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.
    boolean
    C0563664 (UMLS CUI [1])
    C0027552 (UMLS CUI [2,1])
    C0019993 (UMLS CUI [2,2])
    medical condition Unstable status
    Item
    significant unstable medical condition.
    boolean
    C1699700 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    Unable Visit Study
    Item
    anticipated inability to attend scheduled study visits.
    boolean
    C1299582 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C2603343 (UMLS CUI [1,3])
    Compliance behavior Limited
    Item
    patients who in the judgment of the investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    Cytochrome | Serotonin transporter | Genome Testing
    Item
    cytochrome (cyp) & serotonin transporter genomic testing within 5 years.
    boolean
    C0010798 (UMLS CUI [1])
    C0170657 (UMLS CUI [2])
    C0017428 (UMLS CUI [3,1])
    C0039593 (UMLS CUI [3,2])

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