0 Avaliações

ID

13865

Descrição

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

Link

https://clinicaltrials.gov/show/NCT01421342

Palavras-chave

  1. 13/03/2016 13/03/2016 -
Transferido a

13 de março de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Major Depressive Disorder NCT01421342

    Eligibility Major Depressive Disorder NCT01421342

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    dsm-iv diagnosis of single or recurrent, non-psychotic, major depressive disorder
    Descrição

    dsm-iv; major depressive disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0220952 (DSM-IV)
    UMLS CUI [2]
    C1269683 (Major Depressive Disorder)
    SNOMED
    370143000
    currently taking a selective serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitor (snri) or mirtazapine for major depressive disorder
    Descrição

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0360105 (Selective Serotonin Reuptake Inhibitors)
    SNOMED
    373225007
    UMLS CUI [2]
    C3537213 (Serotonin and Norepinephrine Reuptake Inhibitor [EPC])
    UMLS CUI [3]
    C0049506 (mirtazapine)
    SNOMED
    108430001
    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
    Descrição

    antidepressant; therapy major depressive episode

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0003289 (Antidepressive Agents)
    SNOMED
    36236003
    LOINC
    LP18893-5
    UMLS CUI [2,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [2,2]
    C0154409 (Recurrent major depressive episodes)
    SNOMED
    268621008
    age: 18 years of age or older
    Descrição

    age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Exclusion Criteria
    Descrição

    Exclusion Criteria

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

    hypersensitivity study drugs

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,3]
    C0008972 (Clinical Research)
    current treatment with bupropion, aripiprazole or any other antipsychotic agent
    Descrição

    antipsychotic agent bupropion aripiprazole

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0040615 (Antipsychotic Agents)
    SNOMED
    10784006
    LOINC
    LP18073-4
    UMLS CUI [1,2]
    C0085208 (bupropion)
    SNOMED
    96199001
    UMLS CUI [1,3]
    C0299792 (aripiprazole)
    SNOMED
    406785006
    lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis not otherwise specified
    Descrição

    bipolar disorder; schizophrenia; psychosis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005586 (Bipolar Disorder)
    SNOMED
    13746004
    LOINC
    MTHU026189
    UMLS CUI [2]
    C0036341 (Schizophrenia)
    SNOMED
    58214004
    LOINC
    MTHU020814
    UMLS CUI [3]
    C0033975 (Psychotic Disorders)
    SNOMED
    69322001
    current diagnosis of dementia
    Descrição

    dementia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0497327 (Dementia)
    SNOMED
    52448006
    LOINC
    LA20372-1
    current diagnosis of an eating disorder or a seizure disorder
    Descrição

    eating disorder; seizure disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013473 (Eating Disorders)
    SNOMED
    72366004
    UMLS CUI [2]
    C0014544 (Epilepsy)
    SNOMED
    84757009
    LOINC
    MTHU020586
    high suicide risk currently requiring acute intervention (other than outpatient treatment of depression)
    Descrição

    High suicide risk

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1271074 (High suicide risk)
    SNOMED
    394685004
    unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care
    Descrição

    comorbidity; hospitalization

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    UMLS CUI [2]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    requiring immediate hospitalization for psychiatric disorders
    Descrição

    hospitalization psychiatric disorders

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [1,2]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion criteria)
    Descrição

    drug detoxification; Substance Use Disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0025516 (Metabolic Detoxication, Drug)
    UMLS CUI [2]
    C0038586 (Substance Use Disorders)
    taking any concomitant medication that contraindicates any of treatment options or augmenting agents known to have an antidepressant effect
    Descrição

    concomitant medication

    Tipo de dados

    boolean

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

    Study Subject Participation Status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    female - pregnant or lactating or planning to become pregnant
    Descrição

    pregnancy; lactating

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    patient was not able or willing to provide informed consent; or changed mind about participating prior to randomization
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    patient was not referred to the study
    Descrição

    Clinical Research

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0008972 (Clinical Research)

    Similar models

    Eligibility Major Depressive Disorder NCT01421342

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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