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ID

16910

Description

Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00608543

Lien

https://clinicaltrials.gov/show/NCT00608543

Mots-clés

  1. 13/08/2016 13/08/2016 -
Téléchargé le

13 août 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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    Eligibility Major Depressive Disorder NCT00608543

    Eligibility Major Depressive Disorder NCT00608543

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    age 18-65
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    primary diagnosis of major depressive disorder (mdd)
    Description

    Major depressive disorder

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1269683 (Major Depressive Disorder)
    SNOMED
    370143000
    completion of at least 8-12 weeks (and no longer than 6 months) of treatment with escitalopram, citalopram, or sertraline, with at least 6 weeks at an adequate dose (i.e., 20 mg escitalopram; 40 mg citalopram; 150 mg sertraline)
    Description

    Antidepressant therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1099456 (escitalopram)
    SNOMED
    395246009
    UMLS CUI [2]
    C0008845 (citalopram)
    SNOMED
    321986007
    UMLS CUI [3]
    C0074393 (sertraline)
    SNOMED
    321958004
    hamilton rating scale for depression, 17-item (hrsd17) score less than or equal to 14 and/or clinical global impression - severity (cgi-s) score less than or equal to 3
    Description

    Hamilton rating scale for depression

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0451203 (Hamilton rating scale for depression)
    SNOMED
    273503001
    self-reported difficulties with cognition and/or concentration, and an inventory for depressive symptomatology clinician-rated, 30-item (ids-c30) item #16 (concentration and decision making) score less than or equal to 2
    Description

    Difficulties with cognition and/or concentration

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009240 (Cognition)
    UMLS CUI [2]
    C0424098 (Ability to concentrate)
    SNOMED
    247760006
    LOINC
    MTHU051452
    ability to read and write in english (required because instructions for cognitive testing and several questionnaires are available only in english)
    Description

    Language

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1145677 (language ability)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    presence of untreated or unstable comorbid medical condition based on physician information or evidence at examination, such as hypertension, diabetes, hypothyroidism.
    Description

    Comorbidity

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    presence of known cardiovascular disease or seizure disorder.
    Description

    Cardiovascular disease or seizure disorder

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    UMLS CUI [2]
    C0014544 (Epilepsy)
    SNOMED
    84757009
    LOINC
    MTHU020586
    presence of other primary psychiatric disorders or conditions (including depression due to medical conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (i, ii, or not otherwise specified [nos]), schizophrenia, schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse or dependence within the last 6 months)
    Description

    Other primary psychiatric disorders or conditions

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [2]
    C0520618 (Mood disorder with depressive features due to general medical condition)
    SNOMED
    75837004
    UMLS CUI [3]
    C0438696 (Suicidal)
    SNOMED
    267073005
    LOINC
    LA29198-1
    UMLS CUI [4]
    C0033975 (Psychotic Disorders)
    SNOMED
    69322001
    UMLS CUI [5]
    C0005586 (Bipolar Disorder)
    SNOMED
    13746004
    LOINC
    MTHU026189
    UMLS CUI [6]
    C0036341 (Schizophrenia)
    SNOMED
    58214004
    LOINC
    MTHU020814
    UMLS CUI [7]
    C0036337 (Schizoaffective Disorder)
    SNOMED
    191567000
    UMLS CUI [8]
    C0003125 (Anorexia Nervosa)
    SNOMED
    56882008
    UMLS CUI [9]
    C0006370 (Bulimia)
    UMLS CUI [10]
    C0028768 (Obsessive-Compulsive Disorder)
    SNOMED
    191736004
    presence of organic brain injury or dementia, based on a cutoff score of < 20 on the mini mental status examination (mmse).
    Description

    organic brain injury or dementia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0270611 (Brain Injuries)
    SNOMED
    127294003
    UMLS CUI [2,1]
    C0497327 (Dementia)
    SNOMED
    52448006
    LOINC
    LA20372-1
    UMLS CUI [2,2]
    C0451306 (Mini-mental state examination)
    SNOMED
    273617000
    LOINC
    LP156457-6
    concomitant pharmacological or psychotherapeutic treatment (in addition to one ssri as described in inclusion criteria) including but not limited to anxiolytics, neuroleptics, mood stabilizers
    Description

    Concomitant pharmacological or psychotherapeutic treatment

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1707479 (Concomitant Therapy)
    Hospitalization for mental illness within the past year.
    Description

    Hospitalization for mental illness

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [1,2]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    for women, currently pregnant or planning to become pregnant in the next year.
    Description

    pregnant or planning to become pregnant

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C2081645 (Planning to become pregnant)

    Similar models

    Eligibility Major Depressive Disorder NCT00608543

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age 18-65
    boolean
    C0001779 (UMLS CUI [1])
    Major depressive disorder
    Item
    primary diagnosis of major depressive disorder (mdd)
    boolean
    C1269683 (UMLS CUI [1])
    Antidepressant therapy
    Item
    completion of at least 8-12 weeks (and no longer than 6 months) of treatment with escitalopram, citalopram, or sertraline, with at least 6 weeks at an adequate dose (i.e., 20 mg escitalopram; 40 mg citalopram; 150 mg sertraline)
    boolean
    C1099456 (UMLS CUI [1])
    C0008845 (UMLS CUI [2])
    C0074393 (UMLS CUI [3])
    Hamilton rating scale for depression
    Item
    hamilton rating scale for depression, 17-item (hrsd17) score less than or equal to 14 and/or clinical global impression - severity (cgi-s) score less than or equal to 3
    boolean
    C0451203 (UMLS CUI [1])
    Difficulties with cognition and/or concentration
    Item
    self-reported difficulties with cognition and/or concentration, and an inventory for depressive symptomatology clinician-rated, 30-item (ids-c30) item #16 (concentration and decision making) score less than or equal to 2
    boolean
    C0009240 (UMLS CUI [1])
    C0424098 (UMLS CUI [2])
    Language
    Item
    ability to read and write in english (required because instructions for cognitive testing and several questionnaires are available only in english)
    boolean
    C1145677 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Comorbidity
    Item
    presence of untreated or unstable comorbid medical condition based on physician information or evidence at examination, such as hypertension, diabetes, hypothyroidism.
    boolean
    C0009488 (UMLS CUI [1])
    Cardiovascular disease or seizure disorder
    Item
    presence of known cardiovascular disease or seizure disorder.
    boolean
    C0007222 (UMLS CUI [1])
    C0014544 (UMLS CUI [2])
    Other primary psychiatric disorders or conditions
    Item
    presence of other primary psychiatric disorders or conditions (including depression due to medical conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (i, ii, or not otherwise specified [nos]), schizophrenia, schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse or dependence within the last 6 months)
    boolean
    C0004936 (UMLS CUI [1])
    C0520618 (UMLS CUI [2])
    C0438696 (UMLS CUI [3])
    C0033975 (UMLS CUI [4])
    C0005586 (UMLS CUI [5])
    C0036341 (UMLS CUI [6])
    C0036337 (UMLS CUI [7])
    C0003125 (UMLS CUI [8])
    C0006370 (UMLS CUI [9])
    C0028768 (UMLS CUI [10])
    organic brain injury or dementia
    Item
    presence of organic brain injury or dementia, based on a cutoff score of < 20 on the mini mental status examination (mmse).
    boolean
    C0270611 (UMLS CUI [1])
    C0497327 (UMLS CUI [2,1])
    C0451306 (UMLS CUI [2,2])
    Concomitant pharmacological or psychotherapeutic treatment
    Item
    concomitant pharmacological or psychotherapeutic treatment (in addition to one ssri as described in inclusion criteria) including but not limited to anxiolytics, neuroleptics, mood stabilizers
    boolean
    C1707479 (UMLS CUI [1])
    Hospitalization for mental illness
    Item
    Hospitalization for mental illness within the past year.
    boolean
    C0019993 (UMLS CUI [1,1])
    C0004936 (UMLS CUI [1,2])
    pregnant or planning to become pregnant
    Item
    for women, currently pregnant or planning to become pregnant in the next year.
    boolean
    C0032961 (UMLS CUI [1])
    C2081645 (UMLS CUI [2])

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