ID

23995

Beskrivning

Treating Depression With Transcranial Direct Current Stimulation (tDCS); ODM derived from: https://clinicaltrials.gov/show/NCT00481988

Länk

https://clinicaltrials.gov/show/NCT00481988

Nyckelord

Versioner (1)
  1. 2017-07-20 2017-07-20 -
Uppladdad den

20 juli 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depression NCT00481988

Engelsk

Eligibility Depression NCT00481988

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00481988
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
has a diagnosis of a major depressive episode or bipolar disorder and is currently in a major depressive episode (without psychotic features)
Beskrivning

Single major depressive episode | Bipolar Disorder | Psychotic feature Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0005586
UMLS CUI [3,1]
C0743076
UMLS CUI [3,2]
C0332197
total pretreatment hdrs (hamilton depression rating scale)-24 score >= 18 (the hamilton depression rating scale is an interviewer scored tool for assessing the severity of depressive symtoms. the scale ranges from 0 (no symptoms, absence of depression) to 64
Beskrivning

Pretreatment Total Hamilton rating scale for depression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3539076
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0451203
category ham-24 score normal, not depressed 9 or less mildly depressed 10 to 19 moderately depressed 20 to 29 markedly/severely depressed 30 or more)
Beskrivning

Hamilton rating scale for depression

Datatyp

boolean

Alias
UMLS CUI [1]
C0451203
capable and willing to provide informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of depression previously untreated with medication, bipolar disorder, schizophrenia, schizoaffective disorder (non mood disorder), psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), psychotic features in this or previous episodes, amnestic disorder, dementia or mms<24, delirium
Beskrivning

Depressive disorder untreated | Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Mood Disorders Excluded | Psychotic Disorders | Depressive disorder Secondary to Medical condition | Mental Retardation | Substance Dependence | Substance Use Disorders | Nicotine Dependence Excluded | Nicotine abuse Excluded | Psychotic feature Within Depressive episode | Amnestic Disorder | Dementia | Mini-mental state examination | Delirium

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0036337
UMLS CUI [5,1]
C0525045
UMLS CUI [5,2]
C2828389
UMLS CUI [6]
C0033975
UMLS CUI [7,1]
C0011581
UMLS CUI [7,2]
C0175668
UMLS CUI [7,3]
C3843040
UMLS CUI [8]
C0025362
UMLS CUI [9]
C0038580
UMLS CUI [10]
C0038586
UMLS CUI [11,1]
C0028043
UMLS CUI [11,2]
C2828389
UMLS CUI [12,1]
C2363943
UMLS CUI [12,2]
C2828389
UMLS CUI [13,1]
C0743076
UMLS CUI [13,2]
C0332285
UMLS CUI [13,3]
C0349217
UMLS CUI [14]
C0002625
UMLS CUI [15]
C0497327
UMLS CUI [16]
C0451306
UMLS CUI [17]
C0011206
significant current history of autoimmune, endocrine, viral or vascular disorder affecting the brain
Beskrivning

Autoimmune Disease Affecting Brain | Endocrine System Disease Affecting Brain | Virus Disease Affecting Brain | Vascular Disease Affecting Brain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0006104
UMLS CUI [2,1]
C0014130
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0006104
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0006104
UMLS CUI [4,1]
C0042373
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0006104
history of unstable cardiac disease, uncontrolled hypertension, or sleep apnea
Beskrivning

Heart Disease Unstable | Uncontrolled hypertension | Sleep Apnea

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0037315
changes in psychotropic medications within two weeks prior to study entry or patient is unable to maintain stable doses throughout the study trial
Beskrivning

Psychotropic Drugs Change | Psychotropic Drugs Dosage Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0392747
UMLS CUI [2,1]
C0033978
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0443343
subject has an active suicidal plan and/or attempted suicide in the past twelve months
Beskrivning

Planning suicide | Suicide attempt

Datatyp

boolean

Alias
UMLS CUI [1]
C0424001
UMLS CUI [2]
C0038663
patients with a cgi of 6 or greater
Beskrivning

Clinical Global Impression Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C3639708
subject is pregnant or has a positive pregnancy serum test
Beskrivning

Pregnancy | Serum pregnancy test positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0430063
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Similar models

Eligibility Depression NCT00481988

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00481988
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Single major depressive episode | Bipolar Disorder | Psychotic feature Absent
Item
has a diagnosis of a major depressive episode or bipolar disorder and is currently in a major depressive episode (without psychotic features)
boolean
C0024517 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0743076 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Pretreatment Total Hamilton rating scale for depression
Item
total pretreatment hdrs (hamilton depression rating scale)-24 score >= 18 (the hamilton depression rating scale is an interviewer scored tool for assessing the severity of depressive symtoms. the scale ranges from 0 (no symptoms, absence of depression) to 64
boolean
C3539076 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0451203 (UMLS CUI [1,3])
Hamilton rating scale for depression
Item
category ham-24 score normal, not depressed 9 or less mildly depressed 10 to 19 moderately depressed 20 to 29 markedly/severely depressed 30 or more)
boolean
C0451203 (UMLS CUI [1])
Informed Consent
Item
capable and willing to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Depressive disorder untreated | Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Mood Disorders Excluded | Psychotic Disorders | Depressive disorder Secondary to Medical condition | Mental Retardation | Substance Dependence | Substance Use Disorders | Nicotine Dependence Excluded | Nicotine abuse Excluded | Psychotic feature Within Depressive episode | Amnestic Disorder | Dementia | Mini-mental state examination | Delirium
Item
history of depression previously untreated with medication, bipolar disorder, schizophrenia, schizoaffective disorder (non mood disorder), psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), psychotic features in this or previous episodes, amnestic disorder, dementia or mms<24, delirium
boolean
C0011581 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0005586 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0525045 (UMLS CUI [5,1])
C2828389 (UMLS CUI [5,2])
C0033975 (UMLS CUI [6])
C0011581 (UMLS CUI [7,1])
C0175668 (UMLS CUI [7,2])
C3843040 (UMLS CUI [7,3])
C0025362 (UMLS CUI [8])
C0038580 (UMLS CUI [9])
C0038586 (UMLS CUI [10])
C0028043 (UMLS CUI [11,1])
C2828389 (UMLS CUI [11,2])
C2363943 (UMLS CUI [12,1])
C2828389 (UMLS CUI [12,2])
C0743076 (UMLS CUI [13,1])
C0332285 (UMLS CUI [13,2])
C0349217 (UMLS CUI [13,3])
C0002625 (UMLS CUI [14])
C0497327 (UMLS CUI [15])
C0451306 (UMLS CUI [16])
C0011206 (UMLS CUI [17])
Autoimmune Disease Affecting Brain | Endocrine System Disease Affecting Brain | Virus Disease Affecting Brain | Vascular Disease Affecting Brain
Item
significant current history of autoimmune, endocrine, viral or vascular disorder affecting the brain
boolean
C0004364 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0006104 (UMLS CUI [1,3])
C0014130 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0006104 (UMLS CUI [2,3])
C0042769 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0006104 (UMLS CUI [3,3])
C0042373 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0006104 (UMLS CUI [4,3])
Heart Disease Unstable | Uncontrolled hypertension | Sleep Apnea
Item
history of unstable cardiac disease, uncontrolled hypertension, or sleep apnea
boolean
C0018799 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0037315 (UMLS CUI [3])
Psychotropic Drugs Change | Psychotropic Drugs Dosage Unstable
Item
changes in psychotropic medications within two weeks prior to study entry or patient is unable to maintain stable doses throughout the study trial
boolean
C0033978 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0033978 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Planning suicide | Suicide attempt
Item
subject has an active suicidal plan and/or attempted suicide in the past twelve months
boolean
C0424001 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
Clinical Global Impression Questionnaire
Item
patients with a cgi of 6 or greater
boolean
C3639708 (UMLS CUI [1])
Pregnancy | Serum pregnancy test positive
Item
subject is pregnant or has a positive pregnancy serum test
boolean
C0032961 (UMLS CUI [1])
C0430063 (UMLS CUI [2])
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