ID

13865

Beskrivning

VA Augmentation and Switching Treatments for Improving Depression Outcomes; ODM derived from: https://clinicaltrials.gov/show/NCT01421342

Länk

https://clinicaltrials.gov/show/NCT01421342

Nyckelord

  1. 2016-03-13 2016-03-13 -
Uppladdad den

13 mars 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Major Depressive Disorder NCT01421342

    Eligibility Major Depressive Disorder NCT01421342

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    dsm-iv diagnosis of single or recurrent, non-psychotic, major depressive disorder
    Beskrivning

    dsm-iv; major depressive disorder

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0220952
    UMLS CUI [2]
    C1269683
    currently taking a selective serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitor (snri) or mirtazapine for major depressive disorder
    Beskrivning

    selective serotonin reuptake inhibitor; serotonin-norepinephrine reuptake inhibitor; mirtazapine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0360105
    UMLS CUI [2]
    C3537213
    UMLS CUI [3]
    C0049506
    need for "next-step" treatment based on documented suboptimal outcome from current antidepressant treatment for major depressive episode (at least 6 weeks treatment with a qids-c16 >= 16 or at least 8 weeks with a qids-c16 >= 11; and at least 3 weeks at a stable "optimal" dose
    Beskrivning

    antidepressant; therapy major depressive episode

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0003289
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0154409
    age: 18 years of age or older
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior inadequate response after an adequate treatment trial or clear cut intolerance to either of the study medications (aripiprazole or bupropion)
    Beskrivning

    hypersensitivity study drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0008972
    current treatment with bupropion, aripiprazole or any other antipsychotic agent
    Beskrivning

    antipsychotic agent bupropion aripiprazole

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0040615
    UMLS CUI [1,2]
    C0085208
    UMLS CUI [1,3]
    C0299792
    lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis not otherwise specified
    Beskrivning

    bipolar disorder; schizophrenia; psychosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005586
    UMLS CUI [2]
    C0036341
    UMLS CUI [3]
    C0033975
    current diagnosis of dementia
    Beskrivning

    dementia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0497327
    current diagnosis of an eating disorder or a seizure disorder
    Beskrivning

    eating disorder; seizure disorder

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013473
    UMLS CUI [2]
    C0014544
    high suicide risk currently requiring acute intervention (other than outpatient treatment of depression)
    Beskrivning

    High suicide risk

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1271074
    unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care
    Beskrivning

    comorbidity; hospitalization

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C0019993
    requiring immediate hospitalization for psychiatric disorders
    Beskrivning

    hospitalization psychiatric disorders

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993
    UMLS CUI [1,2]
    C0004936
    physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion criteria)
    Beskrivning

    drug detoxification; Substance Use Disorder

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0025516
    UMLS CUI [2]
    C0038586
    taking any concomitant medication that contraindicates any of treatment options or augmenting agents known to have an antidepressant effect
    Beskrivning

    concomitant medication

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    concurrent or recent participation (within the last 30 days) in another conflicting clinical trial with a mental health, investigational drug, or medical device intervention
    Beskrivning

    Study Subject Participation Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    female - pregnant or lactating or planning to become pregnant
    Beskrivning

    pregnancy; lactating

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    patient was not able or willing to provide informed consent; or changed mind about participating prior to randomization
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    patient was not referred to the study
    Beskrivning

    Clinical Research

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0008972

    Similar models

    Eligibility Major Depressive Disorder NCT01421342

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    dsm-iv; major depressive disorder
    Item
    dsm-iv diagnosis of single or recurrent, non-psychotic, major depressive disorder
    boolean
    C0220952 (UMLS CUI [1])
    C1269683 (UMLS CUI [2])
    selective serotonin reuptake inhibitor; serotonin-norepinephrine reuptake inhibitor; mirtazapine
    Item
    currently taking a selective serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitor (snri) or mirtazapine for major depressive disorder
    boolean
    C0360105 (UMLS CUI [1])
    C3537213 (UMLS CUI [2])
    C0049506 (UMLS CUI [3])
    antidepressant; therapy major depressive episode
    Item
    need for "next-step" treatment based on documented suboptimal outcome from current antidepressant treatment for major depressive episode (at least 6 weeks treatment with a qids-c16 >= 16 or at least 8 weeks with a qids-c16 >= 11; and at least 3 weeks at a stable "optimal" dose
    boolean
    C0003289 (UMLS CUI [1])
    C0087111 (UMLS CUI [2,1])
    C0154409 (UMLS CUI [2,2])
    age
    Item
    age: 18 years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    hypersensitivity study drugs
    Item
    prior inadequate response after an adequate treatment trial or clear cut intolerance to either of the study medications (aripiprazole or bupropion)
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0008972 (UMLS CUI [1,3])
    antipsychotic agent bupropion aripiprazole
    Item
    current treatment with bupropion, aripiprazole or any other antipsychotic agent
    boolean
    C0040615 (UMLS CUI [1,1])
    C0085208 (UMLS CUI [1,2])
    C0299792 (UMLS CUI [1,3])
    bipolar disorder; schizophrenia; psychosis
    Item
    lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis not otherwise specified
    boolean
    C0005586 (UMLS CUI [1])
    C0036341 (UMLS CUI [2])
    C0033975 (UMLS CUI [3])
    dementia
    Item
    current diagnosis of dementia
    boolean
    C0497327 (UMLS CUI [1])
    eating disorder; seizure disorder
    Item
    current diagnosis of an eating disorder or a seizure disorder
    boolean
    C0013473 (UMLS CUI [1])
    C0014544 (UMLS CUI [2])
    High suicide risk
    Item
    high suicide risk currently requiring acute intervention (other than outpatient treatment of depression)
    boolean
    C1271074 (UMLS CUI [1])
    comorbidity; hospitalization
    Item
    unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care
    boolean
    C0009488 (UMLS CUI [1])
    C0019993 (UMLS CUI [2])
    hospitalization psychiatric disorders
    Item
    requiring immediate hospitalization for psychiatric disorders
    boolean
    C0019993 (UMLS CUI [1,1])
    C0004936 (UMLS CUI [1,2])
    drug detoxification; Substance Use Disorder
    Item
    physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion criteria)
    boolean
    C0025516 (UMLS CUI [1])
    C0038586 (UMLS CUI [2])
    concomitant medication
    Item
    taking any concomitant medication that contraindicates any of treatment options or augmenting agents known to have an antidepressant effect
    boolean
    C2347852 (UMLS CUI [1])
    Study Subject Participation Status
    Item
    concurrent or recent participation (within the last 30 days) in another conflicting clinical trial with a mental health, investigational drug, or medical device intervention
    boolean
    C2348568 (UMLS CUI [1])
    pregnancy; lactating
    Item
    female - pregnant or lactating or planning to become pregnant
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    informed consent
    Item
    patient was not able or willing to provide informed consent; or changed mind about participating prior to randomization
    boolean
    C0021430 (UMLS CUI [1])
    Clinical Research
    Item
    patient was not referred to the study
    boolean
    C0008972 (UMLS CUI [1])

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