ID

35670

Beskrivning

Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02296437

Länk

https://clinicaltrials.gov/show/NCT02296437

Nyckelord

Versioner (1)
  1. 2019-03-15 2019-03-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depression NCT02296437

Engelsk

Eligibility Depression NCT02296437

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02296437
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. participant ≥ 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. participant meets criteria for a dsm-v major depressive episode. criteria are as follows: five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan.
Beskrivning

Major depressive episode | Symptoms Quantity | Depressed mood | Loss of interest or pleasure | Weight decreased | Weight Gain | Sleeplessness | Hypersomnia | Psychomotor Agitation | Motor retardation | Loss of energy or fatigue | Feelings of worthlessness | Feelings Excessive guilt | Feelings Inappropriate guilt | Reduced concentration Thinking | Ability to make decisions Diminished | Recurrent thoughts of death | Feeling suicidal Recurrent | Suicide attempt | Planning suicide

Datatyp

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0344315
UMLS CUI [4]
C2185938
UMLS CUI [5]
C1262477
UMLS CUI [6]
C0043094
UMLS CUI [7]
C0917801
UMLS CUI [8]
C0917799
UMLS CUI [9]
C3887612
UMLS CUI [10]
C0424230
UMLS CUI [11]
C3176501
UMLS CUI [12]
C0855235
UMLS CUI [13,1]
C1527305
UMLS CUI [13,2]
C1822591
UMLS CUI [14,1]
C1527305
UMLS CUI [14,2]
C1822590
UMLS CUI [15,1]
C0424099
UMLS CUI [15,2]
C0039869
UMLS CUI [16,1]
C1531797
UMLS CUI [16,2]
C0205216
UMLS CUI [17]
C3845525
UMLS CUI [18,1]
C0424000
UMLS CUI [18,2]
C2945760
UMLS CUI [19]
C0038663
UMLS CUI [20]
C0424001
3. madrs score of 20 or more.
Beskrivning

Montgomery-Asberg Depression Rating Scale Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C4054475
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. dsm-v psychotic disorder.
Beskrivning

Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0033975
2. drug or alcohol abuse or dependence (preceding 6 months).
Beskrivning

Substance Use Disorders | Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
3. inadequate response to ect (current episode of depression).
Beskrivning

Response Inadequate Electroconvulsive Therapy | Episode of Depressive disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C0013806
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0011581
4. regular benzodiazepine medication
Beskrivning

Benzodiazepines Regular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005064
UMLS CUI [1,2]
C0205272
5. rapid clinical response required, e.g., due to high suicide risk.
Beskrivning

Requirement Clinical Response Rapid | High suicide risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C4055223
UMLS CUI [1,3]
C0456962
UMLS CUI [2]
C1271074
6. clinically defined neurological disorder or insult.
Beskrivning

Nervous system disorder | Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0038454
7. metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
Beskrivning

Metallic material Cranium Site of electrode | Skull Defect Site of electrode | Skin lesion on scalp Site of electrode | Cut of scalp | Abrasion of scalp | Scalp rash

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0567346
UMLS CUI [1,2]
C0037303
UMLS CUI [1,3]
C0449665
UMLS CUI [2,1]
C2951888
UMLS CUI [2,2]
C1457869
UMLS CUI [2,3]
C0449665
UMLS CUI [3,1]
C2220102
UMLS CUI [3,2]
C0449665
UMLS CUI [4]
C0561273
UMLS CUI [5]
C0432796
UMLS CUI [6]
C0240942
8. pregnancy.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Depression NCT02296437

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02296437
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. participant ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Major depressive episode | Symptoms Quantity | Depressed mood | Loss of interest or pleasure | Weight decreased | Weight Gain | Sleeplessness | Hypersomnia | Psychomotor Agitation | Motor retardation | Loss of energy or fatigue | Feelings of worthlessness | Feelings Excessive guilt | Feelings Inappropriate guilt | Reduced concentration Thinking | Ability to make decisions Diminished | Recurrent thoughts of death | Feeling suicidal Recurrent | Suicide attempt | Planning suicide
Item
2. participant meets criteria for a dsm-v major depressive episode. criteria are as follows: five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan.
boolean
C0024517 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0344315 (UMLS CUI [3])
C2185938 (UMLS CUI [4])
C1262477 (UMLS CUI [5])
C0043094 (UMLS CUI [6])
C0917801 (UMLS CUI [7])
C0917799 (UMLS CUI [8])
C3887612 (UMLS CUI [9])
C0424230 (UMLS CUI [10])
C3176501 (UMLS CUI [11])
C0855235 (UMLS CUI [12])
C1527305 (UMLS CUI [13,1])
C1822591 (UMLS CUI [13,2])
C1527305 (UMLS CUI [14,1])
C1822590 (UMLS CUI [14,2])
C0424099 (UMLS CUI [15,1])
C0039869 (UMLS CUI [15,2])
C1531797 (UMLS CUI [16,1])
C0205216 (UMLS CUI [16,2])
C3845525 (UMLS CUI [17])
C0424000 (UMLS CUI [18,1])
C2945760 (UMLS CUI [18,2])
C0038663 (UMLS CUI [19])
C0424001 (UMLS CUI [20])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
3. madrs score of 20 or more.
boolean
C4054475 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Psychotic Disorders
Item
1. dsm-v psychotic disorder.
boolean
C0033975 (UMLS CUI [1])
Substance Use Disorders | Substance Dependence
Item
2. drug or alcohol abuse or dependence (preceding 6 months).
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Response Inadequate Electroconvulsive Therapy | Episode of Depressive disorder
Item
3. inadequate response to ect (current episode of depression).
boolean
C1704632 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0013806 (UMLS CUI [1,3])
C0332189 (UMLS CUI [2,1])
C0011581 (UMLS CUI [2,2])
Benzodiazepines Regular
Item
4. regular benzodiazepine medication
boolean
C0005064 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Requirement Clinical Response Rapid | High suicide risk
Item
5. rapid clinical response required, e.g., due to high suicide risk.
boolean
C1514873 (UMLS CUI [1,1])
C4055223 (UMLS CUI [1,2])
C0456962 (UMLS CUI [1,3])
C1271074 (UMLS CUI [2])
Nervous system disorder | Cerebrovascular accident
Item
6. clinically defined neurological disorder or insult.
boolean
C0027765 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Metallic material Cranium Site of electrode | Skull Defect Site of electrode | Skin lesion on scalp Site of electrode | Cut of scalp | Abrasion of scalp | Scalp rash
Item
7. metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
boolean
C0567346 (UMLS CUI [1,1])
C0037303 (UMLS CUI [1,2])
C0449665 (UMLS CUI [1,3])
C2951888 (UMLS CUI [2,1])
C1457869 (UMLS CUI [2,2])
C0449665 (UMLS CUI [2,3])
C2220102 (UMLS CUI [3,1])
C0449665 (UMLS CUI [3,2])
C0561273 (UMLS CUI [4])
C0432796 (UMLS CUI [5])
C0240942 (UMLS CUI [6])
Pregnancy
Item
8. pregnancy.
boolean
C0032961 (UMLS CUI [1])
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