ID

15438

Description

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

Link

https://clinicaltrials.gov/show/NCT02339285

Keywords

Versions (1)
  1. 5/31/16 5/31/16 -
Uploaded on

May 31, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02339285

English

Eligibility Major Depressive Disorder NCT02339285

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

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

Data type

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
Description

Major Depressive Disorder Pharmaceutical Preparations Free of

Data type

boolean

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

Hamilton rating scale for depression

Data type

boolean

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

Informed Consent | Comprehension Study Protocol

Data type

boolean

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

Low suicide risk criteria Fulfill

Data type

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
Description

Compliance behavior Study Protocol

Data type

boolean

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

Childbearing Potential Contraceptive methods

Data type

boolean

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

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Operation on brain Previous

Data type

boolean

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

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

Data type

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)
Description

Co-morbid conditions neurological | Epilepsy | Brain Neoplasms

Data type

boolean

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

Able to speak English Language

Data type

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
Description

Pregnancy | Breast Feeding | Female fertility Contraceptive methods Unwilling

Data type

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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Similar models

Eligibility Major Depressive Disorder NCT02339285

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