ID

40438

Description

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

Lien

https://clinicaltrials.gov/show/NCT01707706

Mots-clés

Versions (1)
  1. 21/04/2020 21/04/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

21 avril 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Insomnia NCT01707706

Anglais

Eligibility Insomnia NCT01707706

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

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18 years or above
Description

Age

Type de données

boolean

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

Major Depressive Disorder Previous

Type de données

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

Type de données

boolean

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

Sleeplessness Frequency Duration

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Medical condition Unstable

Type de données

boolean

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

Eligibility Insomnia NCT01707706

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Insomnia NCT01707706
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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