ID

40438

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01707706

Trefwoorden

Versies (1)
  1. 21-04-20 21-04-20 -
Houder van rechten

See clinicaltrials.gov

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21 april 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Insomnia NCT01707706

Engels

Eligibility Insomnia NCT01707706

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Insomnia NCT01707706
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18 years or above
Beschrijving

Age

Datatype

boolean

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

Major Depressive Disorder Previous

Datatype

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
Beschrijving

Sleeplessness

Datatype

boolean

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

Sleeplessness Frequency Duration

Datatype

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
Beschrijving

Insomnia Severity Index

Datatype

boolean

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

Antidepressive Agents Dose Stable

Datatype

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
Beschrijving

Hypnotics Dose Stable

Datatype

boolean

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

Exclusion Criteria

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

Hamilton rating scale for depression

Datatype

boolean

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

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

Datatype

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
Beschrijving

At risk for suicide Hamilton rating scale for depression

Datatype

boolean

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

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

Datatype

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
Beschrijving

Substance Use Disorders | Substance Dependence

Datatype

boolean

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

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datatype

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
Beschrijving

Communicable Disease Near Acupuncture Points | Abscess Near Acupuncture Points

Datatype

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
Beschrijving

Chinese Herbal Drugs Sleeplessness | Non-Prescription Drugs Sleeplessness

Datatype

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
Beschrijving

Acupuncture

Datatype

boolean

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

Medical condition Unstable

Datatype

boolean

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

Eligibility Insomnia NCT01707706

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Insomnia NCT01707706
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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