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ID

40438

Description

Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT01707706

Link

https://clinicaltrials.gov/show/NCT01707706

Keywords

Versions (1)
  1. 4/21/20 4/21/20 -
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See clinicaltrials.gov

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April 21, 2020

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License

Creative Commons BY 4.0
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    Eligibility Insomnia NCT01707706

    English

    Eligibility Insomnia NCT01707706

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Insomnia NCT01707706
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    aged 18 years or above
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    a previous diagnostic and statistical manual of mental disorders-iv major depressive disorder
    Description

    Major Depressive Disorder Previous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1269683
    UMLS CUI [1,2]
    C0205156
    have a current diagnostic and statistical manual of mental disorders-iv diagnosis of insomnia disorder
    Description

    Sleeplessness

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0917801
    insomnia more than 3 nights per week for at least 3 months
    Description

    Sleeplessness Frequency Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0917801
    UMLS CUI [1,2]
    C0439603
    UMLS CUI [1,3]
    C0449238
    insomnia severity scale (isi) total score higher than 15 at screening and baseline visit
    Description

    Insomnia Severity Index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4545806
    use of antidepressants at the same dosage for at least 12 weeks prior to screening visit
    Description

    Antidepressive Agents Dose Stable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003289
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0205360
    hypnotic dosage has not been increased in the last 4 weeks
    Description

    Hypnotics Dose Stable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020591
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0205360
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    have a hamilton depression rating scale scores above 18
    Description

    Hamilton rating scale for depression

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0451203
    have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
    Description

    Sleep Apnea Polysomnography Overnight | Periodic limb movement sleep disorder Polysomnography Overnight

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0037315
    UMLS CUI [1,2]
    C0162701
    UMLS CUI [1,3]
    C0439583
    UMLS CUI [2,1]
    C1561887
    UMLS CUI [2,2]
    C0162701
    UMLS CUI [2,3]
    C0439583
    have suicidal risk as assessed by the hamilton depression rating scale suicidal risk item
    Description

    At risk for suicide Hamilton rating scale for depression

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0563664
    UMLS CUI [1,2]
    C0451203
    have previous history of schizophrenia, other psychotic disorders, and bipolar disorder
    Description

    History of schizophrenia | History of psychotic disorder | Medical History Bipolar Disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0455502
    UMLS CUI [2]
    C3887134
    UMLS CUI [3,1]
    C0262926
    UMLS CUI [3,2]
    C0005586
    have current alcohol or drug abuse and dependence
    Description

    Substance Use Disorders | Substance Dependence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0038580
    pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
    Description

    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C0332197
    have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
    Description

    Communicable Disease Near Acupuncture Points | Abscess Near Acupuncture Points

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C1706276
    UMLS CUI [1,3]
    C0001302
    UMLS CUI [2,1]
    C0000833
    UMLS CUI [2,2]
    C1706276
    UMLS CUI [2,3]
    C0001302
    taking chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
    Description

    Chinese Herbal Drugs Sleeplessness | Non-Prescription Drugs Sleeplessness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013229
    UMLS CUI [1,2]
    C0917801
    UMLS CUI [2,1]
    C0013231
    UMLS CUI [2,2]
    C0917801
    any acupuncture treatment during the previous 12 months prior to baseline and
    Description

    Acupuncture

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0394664
    unstable medical conditions.
    Description

    Medical condition Unstable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0443343
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    Similar models

    Eligibility Insomnia NCT01707706

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Insomnia NCT01707706
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    aged 18 years or above
    boolean
    C0001779 (UMLS CUI [1])
    Major Depressive Disorder Previous
    Item
    a previous diagnostic and statistical manual of mental disorders-iv major depressive disorder
    boolean
    C1269683 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    Sleeplessness
    Item
    have a current diagnostic and statistical manual of mental disorders-iv diagnosis of insomnia disorder
    boolean
    C0917801 (UMLS CUI [1])
    Sleeplessness Frequency Duration
    Item
    insomnia more than 3 nights per week for at least 3 months
    boolean
    C0917801 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    C0449238 (UMLS CUI [1,3])
    Insomnia Severity Index
    Item
    insomnia severity scale (isi) total score higher than 15 at screening and baseline visit
    boolean
    C4545806 (UMLS CUI [1])
    Antidepressive Agents Dose Stable
    Item
    use of antidepressants at the same dosage for at least 12 weeks prior to screening visit
    boolean
    C0003289 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    Hypnotics Dose Stable
    Item
    hypnotic dosage has not been increased in the last 4 weeks
    boolean
    C0020591 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    Item Group
    C0680251 (UMLS CUI)
    Hamilton rating scale for depression
    Item
    have a hamilton depression rating scale scores above 18
    boolean
    C0451203 (UMLS CUI [1])
    Sleep Apnea Polysomnography Overnight | Periodic limb movement sleep disorder Polysomnography Overnight
    Item
    have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
    boolean
    C0037315 (UMLS CUI [1,1])
    C0162701 (UMLS CUI [1,2])
    C0439583 (UMLS CUI [1,3])
    C1561887 (UMLS CUI [2,1])
    C0162701 (UMLS CUI [2,2])
    C0439583 (UMLS CUI [2,3])
    At risk for suicide Hamilton rating scale for depression
    Item
    have suicidal risk as assessed by the hamilton depression rating scale suicidal risk item
    boolean
    C0563664 (UMLS CUI [1,1])
    C0451203 (UMLS CUI [1,2])
    History of schizophrenia | History of psychotic disorder | Medical History Bipolar Disorder
    Item
    have previous history of schizophrenia, other psychotic disorders, and bipolar disorder
    boolean
    C0455502 (UMLS CUI [1])
    C3887134 (UMLS CUI [2])
    C0262926 (UMLS CUI [3,1])
    C0005586 (UMLS CUI [3,2])
    Substance Use Disorders | Substance Dependence
    Item
    have current alcohol or drug abuse and dependence
    boolean
    C0038586 (UMLS CUI [1])
    C0038580 (UMLS CUI [2])
    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
    Item
    pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C0332197 (UMLS CUI [3,3])
    Communicable Disease Near Acupuncture Points | Abscess Near Acupuncture Points
    Item
    have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
    boolean
    C0009450 (UMLS CUI [1,1])
    C1706276 (UMLS CUI [1,2])
    C0001302 (UMLS CUI [1,3])
    C0000833 (UMLS CUI [2,1])
    C1706276 (UMLS CUI [2,2])
    C0001302 (UMLS CUI [2,3])
    Chinese Herbal Drugs Sleeplessness | Non-Prescription Drugs Sleeplessness
    Item
    taking chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
    boolean
    C0013229 (UMLS CUI [1,1])
    C0917801 (UMLS CUI [1,2])
    C0013231 (UMLS CUI [2,1])
    C0917801 (UMLS CUI [2,2])
    Acupuncture
    Item
    any acupuncture treatment during the previous 12 months prior to baseline and
    boolean
    C0394664 (UMLS CUI [1])
    Medical condition Unstable
    Item
    unstable medical conditions.
    boolean
    C3843040 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
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