0 Ratings

ID

16910

Description

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

Link

https://clinicaltrials.gov/show/NCT00608543

Keywords

  1. 8/13/16 8/13/16 -
Uploaded on

August 13, 2016

DOI

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License

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
    age 18-65
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    primary diagnosis of major depressive disorder (mdd)
    Description

    Major depressive disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1269683
    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1099456
    UMLS CUI [2]
    C0008845
    UMLS CUI [3]
    C0074393
    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0451203
    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

    Data type

    boolean

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

    Language

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1145677
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    Comorbidity

    Data type

    boolean

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

    Cardiovascular disease or seizure disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007222
    UMLS CUI [2]
    C0014544
    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    UMLS CUI [2]
    C0520618
    UMLS CUI [3]
    C0438696
    UMLS CUI [4]
    C0033975
    UMLS CUI [5]
    C0005586
    UMLS CUI [6]
    C0036341
    UMLS CUI [7]
    C0036337
    UMLS CUI [8]
    C0003125
    UMLS CUI [9]
    C0006370
    UMLS CUI [10]
    C0028768
    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0270611
    UMLS CUI [2,1]
    C0497327
    UMLS CUI [2,2]
    C0451306
    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

    Data type

    boolean

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

    Hospitalization for mental illness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993
    UMLS CUI [1,2]
    C0004936
    for women, currently pregnant or planning to become pregnant in the next year.
    Description

    pregnant or planning to become pregnant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C2081645

    Similar models

    Eligibility Major Depressive Disorder NCT00608543

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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