ID

18074

Beschrijving

Treatment for Chronic Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00204152

Link

https://clinicaltrials.gov/show/NCT00204152

Trefwoorden

Versies (1)
  1. 18-10-16 18-10-16 -
Geüploaded op

18 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00204152

Engels

Eligibility Major Depressive Disorder NCT00204152

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
depressed male and female subjects between ages 18 to 58 years.
Beschrijving

Age | Feeling depressed

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0497307
current and primary diagnosis of dsm-iv major depressive disorder (e.g., no lifetime history of bipolar i or ii disorder, current anxiety disorders, or current substance dependence disorder (american psychiatric association, 1994).
Beschrijving

Major Depressive Disorder Principal diagnosis | Bipolar I disorder Lifetime | Bipolar II disorder Lifetime | Anxiety Disorders | Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332137
UMLS CUI [2,1]
C0853193
UMLS CUI [2,2]
C4071830
UMLS CUI [3,1]
C0236788
UMLS CUI [3,2]
C4071830
UMLS CUI [4]
C0003469
UMLS CUI [5]
C0038580
should also have upon study entry a score of 14 or higher (moderate depression) on the hamilton rating scale for depression (hrsd; hamilton, 1960) and a score of 20 or higher (moderate depression) on the beck depression inventory ii (bdi-ii; beck et al., 1996a).
Beschrijving

Hamilton rating scale for depression | Moderate depression | Beck depression inventory

Datatype

boolean

Alias
UMLS CUI [1]
C0451203
UMLS CUI [2]
C0588007
UMLS CUI [3]
C0451022
background of high childhood trauma (70-item childhood trauma questionnaire with a total score of 9 or higher).
Beschrijving

child abuse High | child abuse Questionnaires

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008060
UMLS CUI [1,2]
C0205250
UMLS CUI [2,1]
C0008060
UMLS CUI [2,2]
C0034394
reasonably fluent in english to complete the evaluation.
Beschrijving

Able to speak fluently English Language Related Evaluation Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C1261322
UMLS CUI [1,5]
C0205197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of bipolar affective disorder,
Beschrijving

Bipolar Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0005586
history of psychosis (including schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic organic brain syndrome)
Beschrijving

Psychotic Disorders | Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder | Delusional disorder | Organic psychotic condition

Datatype

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0036358
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0011251
UMLS CUI [6]
C0520473
current non-psychotic axis i disorder if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that offered in the project (including anxiety disorders, somatoform disorders, dissociative disorders, or eating disorders, etc.),
Beschrijving

Axis I diagnosis | Anxiety Disorders | Somatoform Disorder | Dissociative disorder | Eating Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0003469
UMLS CUI [3]
C0037650
UMLS CUI [4]
C0012746
UMLS CUI [5]
C0013473
history of substance dependence in the past six months,
Beschrijving

Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
antisocial, borderline, or schizotypal personality disorder,
Beschrijving

Antisocial Personality Disorder | Borderline Personality Disorder | Schizotypal Personality Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0003431
UMLS CUI [2]
C0006012
UMLS CUI [3]
C0036363
evidence of any medical disorder or condition that could cause depression or preclude the use of study treatments,
Beschrijving

Medical condition Evidence Causing Depressive disorder | Medical condition Evidence Excludes Therapy, Investigational

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0011581
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C0949266
current treatment with catecholaminergic antihypertensive medication, including reserpine, beta-blockers, clonidine, alphamethyldopa, etc. (diuretics, ace inhibitors and calcium channel inhibitors will be allowed),
Beschrijving

Antihypertensive Agents Associated with Catecholamines | Reserpine | Adrenergic beta-Antagonists | Clonidine | Methyldopa | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Calcium Channel Blockers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0007412
UMLS CUI [2]
C0035179
UMLS CUI [3]
C0001645
UMLS CUI [4]
C0009014
UMLS CUI [5]
C0025741
UMLS CUI [6]
C0012798
UMLS CUI [7]
C0003015
UMLS CUI [8]
C0006684
clear indication of secondary gain (e.g., court ordered treatment or compensation issues),
Beschrijving

Court Ordered Treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0870367
current suicide risk sufficient to preclude treatment on an outpatient basis (any patient scoring 3 or above on the suicide item on the hrsd or bdi must be cleared for study participation by the pi).
Beschrijving

Suicide risk assessment Excludes Outpatient Therapeutic procedure | Hamilton rating scale for depression | Beck depression inventory

Datatype

boolean

Alias
UMLS CUI [1,1]
C0558000
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0029921
UMLS CUI [1,4]
C0087111
UMLS CUI [2]
C0451203
UMLS CUI [3]
C0451022
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Similar models

Eligibility Major Depressive Disorder NCT00204152

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Feeling depressed
Item
depressed male and female subjects between ages 18 to 58 years.
boolean
C0001779 (UMLS CUI [1])
C0497307 (UMLS CUI [2])
Major Depressive Disorder Principal diagnosis | Bipolar I disorder Lifetime | Bipolar II disorder Lifetime | Anxiety Disorders | Substance Dependence
Item
current and primary diagnosis of dsm-iv major depressive disorder (e.g., no lifetime history of bipolar i or ii disorder, current anxiety disorders, or current substance dependence disorder (american psychiatric association, 1994).
boolean
C1269683 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
C0853193 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C0236788 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
C0003469 (UMLS CUI [4])
C0038580 (UMLS CUI [5])
Hamilton rating scale for depression | Moderate depression | Beck depression inventory
Item
should also have upon study entry a score of 14 or higher (moderate depression) on the hamilton rating scale for depression (hrsd; hamilton, 1960) and a score of 20 or higher (moderate depression) on the beck depression inventory ii (bdi-ii; beck et al., 1996a).
boolean
C0451203 (UMLS CUI [1])
C0588007 (UMLS CUI [2])
C0451022 (UMLS CUI [3])
child abuse High | child abuse Questionnaires
Item
background of high childhood trauma (70-item childhood trauma questionnaire with a total score of 9 or higher).
boolean
C0008060 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C0008060 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
Able to speak fluently English Language Related Evaluation Completion
Item
reasonably fluent in english to complete the evaluation.
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0205197 (UMLS CUI [1,5])
Item Group
C0680251 (UMLS CUI)
Bipolar Disorder
Item
history of bipolar affective disorder,
boolean
C0005586 (UMLS CUI [1])
Psychotic Disorders | Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder | Delusional disorder | Organic psychotic condition
Item
history of psychosis (including schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic organic brain syndrome)
boolean
C0033975 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0036358 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0011251 (UMLS CUI [5])
C0520473 (UMLS CUI [6])
Axis I diagnosis | Anxiety Disorders | Somatoform Disorder | Dissociative disorder | Eating Disorders
Item
current non-psychotic axis i disorder if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that offered in the project (including anxiety disorders, somatoform disorders, dissociative disorders, or eating disorders, etc.),
boolean
C0270287 (UMLS CUI [1])
C0003469 (UMLS CUI [2])
C0037650 (UMLS CUI [3])
C0012746 (UMLS CUI [4])
C0013473 (UMLS CUI [5])
Substance Dependence
Item
history of substance dependence in the past six months,
boolean
C0038580 (UMLS CUI [1])
Antisocial Personality Disorder | Borderline Personality Disorder | Schizotypal Personality Disorder
Item
antisocial, borderline, or schizotypal personality disorder,
boolean
C0003431 (UMLS CUI [1])
C0006012 (UMLS CUI [2])
C0036363 (UMLS CUI [3])
Medical condition Evidence Causing Depressive disorder | Medical condition Evidence Excludes Therapy, Investigational
Item
evidence of any medical disorder or condition that could cause depression or preclude the use of study treatments,
boolean
C3843040 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0011581 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0949266 (UMLS CUI [2,4])
Antihypertensive Agents Associated with Catecholamines | Reserpine | Adrenergic beta-Antagonists | Clonidine | Methyldopa | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Calcium Channel Blockers
Item
current treatment with catecholaminergic antihypertensive medication, including reserpine, beta-blockers, clonidine, alphamethyldopa, etc. (diuretics, ace inhibitors and calcium channel inhibitors will be allowed),
boolean
C0003364 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0007412 (UMLS CUI [1,3])
C0035179 (UMLS CUI [2])
C0001645 (UMLS CUI [3])
C0009014 (UMLS CUI [4])
C0025741 (UMLS CUI [5])
C0012798 (UMLS CUI [6])
C0003015 (UMLS CUI [7])
C0006684 (UMLS CUI [8])
Court Ordered Treatment
Item
clear indication of secondary gain (e.g., court ordered treatment or compensation issues),
boolean
C0870367 (UMLS CUI [1])
Suicide risk assessment Excludes Outpatient Therapeutic procedure | Hamilton rating scale for depression | Beck depression inventory
Item
current suicide risk sufficient to preclude treatment on an outpatient basis (any patient scoring 3 or above on the suicide item on the hrsd or bdi must be cleared for study participation by the pi).
boolean
C0558000 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0029921 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0451203 (UMLS CUI [2])
C0451022 (UMLS CUI [3])
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