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ID

33639

Description

DBS for Treatment Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01983904

Link

https://clinicaltrials.gov/show/NCT01983904

Keywords

Versions (1)
  1. 12/17/18 12/17/18 -
Copyright Holder

See clinicaltrials.gov

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December 17, 2018

DOI

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License

Creative Commons BY 4.0
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    Eligibility Depressive Disorder, Treatment-Resistant NCT01983904

    English

    Eligibility Depressive Disorder, Treatment-Resistant NCT01983904

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age 20-60
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    diagnosis of major depressive (mdd)or bipolar disorder(bp)determined independently by 2 study psychiatrists
    Description

    Major Depressive Disorder | Bipolar Disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1269683
    UMLS CUI [2]
    C0005586
    current major depressive episode of >1 year duration, treatment-resistant (meaning failure to respond to 4 different classes of antidepressants, including augmentation or combination strategies with lithium, atypical antipsychotics, anticonvulsants, antidepressants, evidence-based psychotherapy, cbt, or electroconvulsive treatment despite adequate dosage, duration and compliance)
    Description

    Major depressive episode Duration Unresponsive to Treatment | Antidepressive Agents Class Quantity failed | Combined Modality Therapy | Lithium | Atypical antipsychotic | Anticonvulsants | Psychotherapy | Cognitive Therapy | Electroconvulsive Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024517
    UMLS CUI [1,2]
    C0449238
    UMLS CUI [1,3]
    C0205269
    UMLS CUI [2,1]
    C0003289
    UMLS CUI [2,2]
    C0456387
    UMLS CUI [2,3]
    C1265611
    UMLS CUI [2,4]
    C0231175
    UMLS CUI [3]
    C0009429
    UMLS CUI [4]
    C0023870
    UMLS CUI [5]
    C1276996
    UMLS CUI [6]
    C0003286
    UMLS CUI [7]
    C0033968
    UMLS CUI [8]
    C0009244
    UMLS CUI [9]
    C0013806
    minimum score of 20 (out of 52) on the 17 item hamilton depression rating scale (hdrs)
    Description

    Hamilton Depression Rating Scale 17 Item Clinical Classification

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3639712
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    other axis i psychiatric disorders including schizophrenia, psychosis, active suicidal ideation over previous 6 months
    Description

    Axis I diagnosis | Schizophrenia | Psychotic Disorders | Feeling suicidal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0270287
    UMLS CUI [2]
    C0036341
    UMLS CUI [3]
    C0033975
    UMLS CUI [4]
    C0424000
    cerebrovascular risk factors, previous stroke, head injury and neurodegenerative disorders, pregnancy, medical and general contraindications for dbs surgery (e.g. cardiac pacemaker/defibrillator)
    Description

    Risk factors Cerebrovascular | Cerebrovascular accident | Craniocerebral Trauma | Neurodegenerative Disorders | Pregnancy | Medical contraindication Deep Brain Stimulation | Contraindication Deep Brain Stimulation | Artificial cardiac pacemaker | Cardiac defibrillator

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0035648
    UMLS CUI [1,2]
    C1880018
    UMLS CUI [2]
    C0038454
    UMLS CUI [3]
    C0018674
    UMLS CUI [4]
    C0524851
    UMLS CUI [5]
    C0032961
    UMLS CUI [6,1]
    C1301624
    UMLS CUI [6,2]
    C0394162
    UMLS CUI [7,1]
    C0522473
    UMLS CUI [7,2]
    C0394162
    UMLS CUI [8]
    C0030163
    UMLS CUI [9]
    C1391956
    age >60
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    diabetes
    Description

    Diabetes Mellitus

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011849
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    Similar models

    Eligibility Depressive Disorder, Treatment-Resistant NCT01983904

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age 20-60
    boolean
    C0001779 (UMLS CUI [1])
    Major Depressive Disorder | Bipolar Disorder
    Item
    diagnosis of major depressive (mdd)or bipolar disorder(bp)determined independently by 2 study psychiatrists
    boolean
    C1269683 (UMLS CUI [1])
    C0005586 (UMLS CUI [2])
    Major depressive episode Duration Unresponsive to Treatment | Antidepressive Agents Class Quantity failed | Combined Modality Therapy | Lithium | Atypical antipsychotic | Anticonvulsants | Psychotherapy | Cognitive Therapy | Electroconvulsive Therapy
    Item
    current major depressive episode of >1 year duration, treatment-resistant (meaning failure to respond to 4 different classes of antidepressants, including augmentation or combination strategies with lithium, atypical antipsychotics, anticonvulsants, antidepressants, evidence-based psychotherapy, cbt, or electroconvulsive treatment despite adequate dosage, duration and compliance)
    boolean
    C0024517 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    C0205269 (UMLS CUI [1,3])
    C0003289 (UMLS CUI [2,1])
    C0456387 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    C0231175 (UMLS CUI [2,4])
    C0009429 (UMLS CUI [3])
    C0023870 (UMLS CUI [4])
    C1276996 (UMLS CUI [5])
    C0003286 (UMLS CUI [6])
    C0033968 (UMLS CUI [7])
    C0009244 (UMLS CUI [8])
    C0013806 (UMLS CUI [9])
    Hamilton Depression Rating Scale 17 Item Clinical Classification
    Item
    minimum score of 20 (out of 52) on the 17 item hamilton depression rating scale (hdrs)
    boolean
    C3639712 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Axis I diagnosis | Schizophrenia | Psychotic Disorders | Feeling suicidal
    Item
    other axis i psychiatric disorders including schizophrenia, psychosis, active suicidal ideation over previous 6 months
    boolean
    C0270287 (UMLS CUI [1])
    C0036341 (UMLS CUI [2])
    C0033975 (UMLS CUI [3])
    C0424000 (UMLS CUI [4])
    Risk factors Cerebrovascular | Cerebrovascular accident | Craniocerebral Trauma | Neurodegenerative Disorders | Pregnancy | Medical contraindication Deep Brain Stimulation | Contraindication Deep Brain Stimulation | Artificial cardiac pacemaker | Cardiac defibrillator
    Item
    cerebrovascular risk factors, previous stroke, head injury and neurodegenerative disorders, pregnancy, medical and general contraindications for dbs surgery (e.g. cardiac pacemaker/defibrillator)
    boolean
    C0035648 (UMLS CUI [1,1])
    C1880018 (UMLS CUI [1,2])
    C0038454 (UMLS CUI [2])
    C0018674 (UMLS CUI [3])
    C0524851 (UMLS CUI [4])
    C0032961 (UMLS CUI [5])
    C1301624 (UMLS CUI [6,1])
    C0394162 (UMLS CUI [6,2])
    C0522473 (UMLS CUI [7,1])
    C0394162 (UMLS CUI [7,2])
    C0030163 (UMLS CUI [8])
    C1391956 (UMLS CUI [9])
    Age
    Item
    age >60
    boolean
    C0001779 (UMLS CUI [1])
    Diabetes Mellitus
    Item
    diabetes
    boolean
    C0011849 (UMLS CUI [1])
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