ID

35651

Beschreibung

Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT); ODM derived from: https://clinicaltrials.gov/show/NCT01974076

Link

https://clinicaltrials.gov/show/NCT01974076

Stichworte

Versionen (1)
  1. 13.03.19 13.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Depression NCT01974076

Englisch

Eligibility Depression NCT01974076

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01974076
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. participants will be ≥ 18 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. have a dsm-iv diagnosis of major depressive episode of minimum 4 weeks duration.
Beschreibung

Major depressive episode Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
3. madrs score ≥ 20 at study entry.
Beschreibung

Montgomery-Asberg Depression Rating Scale Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1]
C4054475
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. participant is unable to give informed consent.
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
2. dsm-iv diagnosis of psychotic disorder (lifetime).
Beschreibung

Psychotic Disorder Lifetime

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C4071830
3. bipolar disorder diagnosis and not on a mood stabiliser.
Beschreibung

Bipolar Disorder | Mood Stabilizer Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2,1]
C2917435
UMLS CUI [2,2]
C0332197
4. eating disorder (current or within past year).
Beschreibung

Eating Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0013473
5. obsessive compulsive disorder (lifetime).
Beschreibung

Obsessive-Compulsive Disorder Lifetime

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0028768
UMLS CUI [1,2]
C4071830
6. post-traumatic stress disorder (current or within past year).
Beschreibung

Post-Traumatic Stress Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038436
7. mental retardation.
Beschreibung

Mental Retardation

Datentyp

boolean

Alias
UMLS CUI [1]
C0025362
8. drug or alcohol abuse or dependence (preceding 3 months).
Beschreibung

Substance Use Disorders | Substance Dependence

Datentyp

boolean

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

Response Inadequate Electroconvulsive Therapy | Episode of Depressive disorder

Datentyp

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
10. rapid clinical response required, e.g., high suicide risk, inanition or psychosis.
Beschreibung

Requirement Clinical Response Rapid | High suicide risk | Inanition | Psychotic Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C4055223
UMLS CUI [1,3]
C0456962
UMLS CUI [2]
C1271074
UMLS CUI [3]
C0392513
UMLS CUI [4]
C0033975
11. clinically defined neurological disorder or insult.
Beschreibung

Nervous system disorder | Cerebrovascular accident

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0567346
UMLS CUI [1,2]
C1279062
UMLS CUI [2,1]
C2951888
UMLS CUI [2,2]
C1457869
UMLS CUI [3]
C2220102
UMLS CUI [4]
C0561273
UMLS CUI [5]
C0432796
UMLS CUI [6]
C0240942
13. pregnancy.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
14. concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
Beschreibung

Benzodiazepines Active Long-term | Ritalin Active Long-term | Dextroamphetamine Active Long-term

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005064
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0443252
UMLS CUI [2,1]
C0728759
UMLS CUI [2,2]
C0205177
UMLS CUI [2,3]
C0443252
UMLS CUI [3,1]
C0011812
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C0443252
15. change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial.
Beschreibung

Psychotropic Drugs Change

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0392747
16. participant becomes hypomanic or manic, as defined by dsm-iv.
Beschreibung

Hypomania | Manic

Datentyp

boolean

Alias
UMLS CUI [1]
C0241934
UMLS CUI [2]
C0338831
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Ähnliche Modelle

Eligibility Depression NCT01974076

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01974076
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. participants will be ≥ 18 years old.
boolean
C0001779 (UMLS CUI [1])
Major depressive episode Duration
Item
2. have a dsm-iv diagnosis of major depressive episode of minimum 4 weeks duration.
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
3. madrs score ≥ 20 at study entry.
boolean
C4054475 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
1. participant is unable to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Psychotic Disorder Lifetime
Item
2. dsm-iv diagnosis of psychotic disorder (lifetime).
boolean
C0033975 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
Bipolar Disorder | Mood Stabilizer Absent
Item
3. bipolar disorder diagnosis and not on a mood stabiliser.
boolean
C0005586 (UMLS CUI [1])
C2917435 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Eating Disorder
Item
4. eating disorder (current or within past year).
boolean
C0013473 (UMLS CUI [1])
Obsessive-Compulsive Disorder Lifetime
Item
5. obsessive compulsive disorder (lifetime).
boolean
C0028768 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
Post-Traumatic Stress Disorder
Item
6. post-traumatic stress disorder (current or within past year).
boolean
C0038436 (UMLS CUI [1])
Mental Retardation
Item
7. mental retardation.
boolean
C0025362 (UMLS CUI [1])
Substance Use Disorders | Substance Dependence
Item
8. drug or alcohol abuse or dependence (preceding 3 months).
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Response Inadequate Electroconvulsive Therapy | Episode of Depressive disorder
Item
9. 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])
Requirement Clinical Response Rapid | High suicide risk | Inanition | Psychotic Disorders
Item
10. rapid clinical response required, e.g., high suicide risk, inanition or psychosis.
boolean
C1514873 (UMLS CUI [1,1])
C4055223 (UMLS CUI [1,2])
C0456962 (UMLS CUI [1,3])
C1271074 (UMLS CUI [2])
C0392513 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
Nervous system disorder | Cerebrovascular accident
Item
11. clinically defined neurological disorder or insult.
boolean
C0027765 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Metallic material Cranium | Skull Defect | Skin lesion on scalp | Cut of scalp | Abrasion of scalp | Scalp rash
Item
12. metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
boolean
C0567346 (UMLS CUI [1,1])
C1279062 (UMLS CUI [1,2])
C2951888 (UMLS CUI [2,1])
C1457869 (UMLS CUI [2,2])
C2220102 (UMLS CUI [3])
C0561273 (UMLS CUI [4])
C0432796 (UMLS CUI [5])
C0240942 (UMLS CUI [6])
Pregnancy
Item
13. pregnancy.
boolean
C0032961 (UMLS CUI [1])
Benzodiazepines Active Long-term | Ritalin Active Long-term | Dextroamphetamine Active Long-term
Item
14. concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
boolean
C0005064 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C0728759 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
C0011812 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
Psychotropic Drugs Change
Item
15. change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial.
boolean
C0033978 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Hypomania | Manic
Item
16. participant becomes hypomanic or manic, as defined by dsm-iv.
boolean
C0241934 (UMLS CUI [1])
C0338831 (UMLS CUI [2])
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