0 Bedömningar

ID

15044

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02286440

Nyckelord

  1. 2016-05-12 2016-05-12 -
Uppladdad den

12 maj 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Depression NCT02286440

    Eligibility Depression NCT02286440

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

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age 13-18, male or female, any race/ethnicity
    Beskrivning

    Age | Racial group | Ethnic group

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0034510
    UMLS CUI [3]
    C0015031
    treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
    Beskrivning

    Indication Pharmacotherapy Part of Comprehensive treatment program

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0013216
    UMLS CUI [1,3]
    C1292711
    UMLS CUI [1,4]
    C0814471
    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)
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0024517
    UMLS CUI [2]
    C0005586
    UMLS CUI [3,1]
    C3897634
    UMLS CUI [3,2]
    C2363919
    UMLS CUI [3,3]
    C0681889
    ability to provide informed consent
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    inability to speak english
    Beskrivning

    Able to speak English Language

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0564215
    UMLS CUI [1,2]
    C0376245
    inability or lack of willingness to provide informed consent and assent.
    Beskrivning

    Unable Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1299582
    UMLS CUI [1,2]
    C0021430
    axis i diagnoses: autism spectrum disorder, anorexia nervosa, schizophreniform, and schizophrenia.
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0270287
    UMLS CUI [2]
    C1510586
    UMLS CUI [3]
    C0003125
    UMLS CUI [4]
    C0036358
    UMLS CUI [5]
    C0036341
    psychotropic medication change (including dosage) between screening & randomization visits.
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0033978
    UMLS CUI [1,2]
    C0580105
    UMLS CUI [2,1]
    C0033978
    UMLS CUI [2,2]
    C1608430
    UMLS CUI [3]
    C0220908
    UMLS CUI [4]
    C0034656
    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
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1136324
    UMLS CUI [1,2]
    C0243161
    UMLS CUI [2]
    C0038586
    UMLS CUI [3]
    C0028040
    UMLS CUI [4]
    C0006644
    UMLS CUI [5]
    C0678449
    UMLS CUI [6]
    C0544452
    serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.
    Beskrivning

    At risk for suicide | Needs Hospitalization

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0563664
    UMLS CUI [2,1]
    C0027552
    UMLS CUI [2,2]
    C0019993
    significant unstable medical condition.
    Beskrivning

    medical condition Unstable status

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1699700
    UMLS CUI [1,2]
    C0443343
    anticipated inability to attend scheduled study visits.
    Beskrivning

    Unable Visit Study

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1299582
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C2603343
    patients who in the judgment of the investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol.
    Beskrivning

    Compliance behavior Limited

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    cytochrome (cyp) & serotonin transporter genomic testing within 5 years.
    Beskrivning

    Cytochrome | Serotonin transporter | Genome Testing

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0010798
    UMLS CUI [2]
    C0170657
    UMLS CUI [3,1]
    C0017428
    UMLS CUI [3,2]
    C0039593

    Similar models

    Eligibility Depression NCT02286440

    1. StudyEvent: Eligibility
      1. Eligibility Depression NCT02286440
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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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