ID

15438

Beschreibung

Transcranial alternatinG Current stimuLation for mAjor Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT02339285

Link

https://clinicaltrials.gov/show/NCT02339285

Stichworte

Versionen (1)
  1. 31.05.16 31.05.16 -
Hochgeladen am

31. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02339285

Englisch

Eligibility Major Depressive Disorder NCT02339285

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, 18-65 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
dsm-iv diagnosis of mdd; unipolar, non-psychotic
Beschreibung

Major Depressive Disorder DSM-IV | Unipolar Depression | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0220952
UMLS CUI [2]
C0041696
UMLS CUI [3]
C0743081
6 months free of any mdd related medications
Beschreibung

Major Depressive Disorder Pharmaceutical Preparations Free of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332296
hamilton depression rating scale score >17
Beschreibung

Hamilton rating scale for depression

Datentyp

boolean

Alias
UMLS CUI [1]
C0451203
capacity to understand all relevant risks and potential benefits of the study (informed consent)
Beschreibung

Informed Consent | Comprehension Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
meet criteria for low suicide risk
Beschreibung

Low suicide risk criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1271076
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
willing to comply with all study procedures and be available to do so for the duration of the study
Beschreibung

Compliance behavior Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
women of reproductive potential must use highly effective contraception
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
dsm-iv diagnosis of alcohol of substance abuse (other than nicotine) within the last month or a dsm-iv diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
Beschreibung

Substance Use Disorders DSM-IV | Nicotine abuse | Substance Dependence DSM-IV | Nicotine Dependence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0220952
UMLS CUI [2]
C2363943
UMLS CUI [3,1]
C0038580
UMLS CUI [3,2]
C0220952
UMLS CUI [4]
C0028043
medical or neurological illness (unstable cardiac disease, aids, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation
Beschreibung

Illness | nervous system disorder | Heart Diseases Unstable status | Acquired Immunodeficiency Syndrome | Malignant Neoplasms | Liver diseases | Renal Insufficiency | Therapeutic procedure Interferes with Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C0027765
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [4]
C0001175
UMLS CUI [5]
C0006826
UMLS CUI [6]
C0023895
UMLS CUI [7]
C1565489
UMLS CUI [8,1]
C0087111
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C2348568
history of traumatic brain injury, reoccurring seizures or later cognitive rehabilitation, or causing cognitive sequelae
Beschreibung

Traumatic Brain Injury | Recurrent seizures | Cognitive rehabilitation | Sequelae cognitive causing

Datentyp

boolean

Alias
UMLS CUI [1]
C0876926
UMLS CUI [2]
C0748607
UMLS CUI [3]
C0870303
UMLS CUI [4,1]
C0243088
UMLS CUI [4,2]
C1516691
UMLS CUI [4,3]
C0678227
prior brain surgery
Beschreibung

Operation on brain Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0195775
UMLS CUI [1,2]
C0205156
any brain devices/implants, including cochlear implants and aneurysm clips
Beschreibung

Brain Medical Device | Brain Implant | Cochlear Implants | Aneurysm clip

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006104
UMLS CUI [1,2]
C0025080
UMLS CUI [2,1]
C0006104
UMLS CUI [2,2]
C0021102
UMLS CUI [3]
C0009199
UMLS CUI [4]
C0179977
co-morbid neurological condition (i.e. seizure disorder, brain tumor)
Beschreibung

Co-morbid conditions neurological | Epilepsy | Brain Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1275743
UMLS CUI [1,2]
C0205494
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0006118
non english speakers
Beschreibung

Able to speak English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation
Beschreibung

Pregnancy | Breast Feeding | Female fertility Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C1955260
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
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Ähnliche Modelle

Eligibility Major Depressive Disorder NCT02339285

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, 18-65 years old
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder DSM-IV | Unipolar Depression | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE
Item
dsm-iv diagnosis of mdd; unipolar, non-psychotic
boolean
C1269683 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C0041696 (UMLS CUI [2])
C0743081 (UMLS CUI [3])
Major Depressive Disorder Pharmaceutical Preparations Free of
Item
6 months free of any mdd related medications
boolean
C1269683 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
Hamilton rating scale for depression
Item
hamilton depression rating scale score >17
boolean
C0451203 (UMLS CUI [1])
Informed Consent | Comprehension Study Protocol
Item
capacity to understand all relevant risks and potential benefits of the study (informed consent)
boolean
C0021430 (UMLS CUI [1])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Low suicide risk criteria Fulfill
Item
meet criteria for low suicide risk
boolean
C1271076 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Compliance behavior Study Protocol
Item
willing to comply with all study procedures and be available to do so for the duration of the study
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
women of reproductive potential must use highly effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders DSM-IV | Nicotine abuse | Substance Dependence DSM-IV | Nicotine Dependence
Item
dsm-iv diagnosis of alcohol of substance abuse (other than nicotine) within the last month or a dsm-iv diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
boolean
C0038586 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C2363943 (UMLS CUI [2])
C0038580 (UMLS CUI [3,1])
C0220952 (UMLS CUI [3,2])
C0028043 (UMLS CUI [4])
Illness | nervous system disorder | Heart Diseases Unstable status | Acquired Immunodeficiency Syndrome | Malignant Neoplasms | Liver diseases | Renal Insufficiency | Therapeutic procedure Interferes with Study Subject Participation Status
Item
medical or neurological illness (unstable cardiac disease, aids, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation
boolean
C0221423 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0001175 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C1565489 (UMLS CUI [7])
C0087111 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
Traumatic Brain Injury | Recurrent seizures | Cognitive rehabilitation | Sequelae cognitive causing
Item
history of traumatic brain injury, reoccurring seizures or later cognitive rehabilitation, or causing cognitive sequelae
boolean
C0876926 (UMLS CUI [1])
C0748607 (UMLS CUI [2])
C0870303 (UMLS CUI [3])
C0243088 (UMLS CUI [4,1])
C1516691 (UMLS CUI [4,2])
C0678227 (UMLS CUI [4,3])
Operation on brain Previous
Item
prior brain surgery
boolean
C0195775 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Brain Medical Device | Brain Implant | Cochlear Implants | Aneurysm clip
Item
any brain devices/implants, including cochlear implants and aneurysm clips
boolean
C0006104 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
C0006104 (UMLS CUI [2,1])
C0021102 (UMLS CUI [2,2])
C0009199 (UMLS CUI [3])
C0179977 (UMLS CUI [4])
Co-morbid conditions neurological | Epilepsy | Brain Neoplasms
Item
co-morbid neurological condition (i.e. seizure disorder, brain tumor)
boolean
C1275743 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
C0014544 (UMLS CUI [2])
C0006118 (UMLS CUI [3])
Able to speak English Language
Item
non english speakers
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Female fertility Contraceptive methods Unwilling
Item
pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1955260 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
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