ID

21780

Description

Treating Refractory Major Depressive Disorder With Repetitive Transcranial Magnetic Stimulation; ODM derived from: https://clinicaltrials.gov/show/NCT00305045

Lien

https://clinicaltrials.gov/show/NCT00305045

Mots-clés

Versions (1)
  1. 30/04/2017 30/04/2017 -
Téléchargé le

30 avril 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Major Depressive Disorder NCT00305045

Anglais

Eligibility Major Depressive Disorder NCT00305045

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
are voluntary and competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study (based on the maccat-cr)
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
have a structured clinical interview for dsm-iv (scid) confirmed dsm-iv diagnosis of mdd with no co-morbid borderline personality disorder and/or antisocial personality disorder, as confirmed by the structured clinical interview for dsm-iv axis ii disorders (scid-ii)
Description

Major Depressive Disorder | Borderline Personality Disorder Absent | Antisocial Personality Disorder Absent

Type de données

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2,1]
C0006012
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0003431
UMLS CUI [3,2]
C0332197
are between the ages of 18 and 85
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
have failed to achieve a clinical response to at least 2 separate antidepressant trials of sufficient dose for at least 6 weeks, according to stage ii criteria outlined by thase et al., or could not tolerate at least 2 trials of antidepressant medication
Description

Antidepressive Agents Quantity Dosage | Disease stage Absent response to treatment | Intolerance to Antidepressive Agents Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0178602
UMLS CUI [2,1]
C0699749
UMLS CUI [2,2]
C0438286
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0003289
UMLS CUI [3,3]
C1265611
have a score greater than or equal to 22 on the 17-item ham-d
Description

Hamilton Depression Rating Scale 17 Item Questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C3639712
no major, unstable medical and/or neurological conditions, such as seizures, stroke, hypertension, diabetes, coronary artery disease, thyroid problems, respiratory illness, allergies and presence of metal implants.
Description

Medical condition Unstable Major Absent | nervous system disorder Unstable Major Absent | Seizures | Cerebrovascular accident | Hypertensive disease | Diabetes Mellitus | Coronary Artery Disease | thyroid problem | Respiration Disorders | Hypersensitivity | Metallic implant Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0205164
UMLS CUI [2,4]
C0332197
UMLS CUI [3]
C0036572
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0020538
UMLS CUI [6]
C0011849
UMLS CUI [7]
C1956346
UMLS CUI [8]
C0851024
UMLS CUI [9]
C0035204
UMLS CUI [10]
C0020517
UMLS CUI [11,1]
C3693688
UMLS CUI [11,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a history of dsm-iv substance dependence in the last 6 months, and have dsm-iv substance abuse in the last month
Description

Substance Dependence | Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
history of self-harm behaviour in past 6 months
Description

Self-Injurious Behavior

Type de données

boolean

Alias
UMLS CUI [1]
C0085271
have a concomitant major, unstable medical or neurologic illness, or have had a history of seizures
Description

Illness Unstable Major | nervous system disorder Unstable Major | Seizures

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205164
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0205164
UMLS CUI [3]
C0036572
are acutely suicidal
Description

Suicidal

Type de données

boolean

Alias
UMLS CUI [1]
C0438696
are pregnant
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
have metal implants
Description

metallic device / implant

Type de données

boolean

Alias
UMLS CUI [1]
C3693688
are currently (or in the last 4 weeks) taking: (1) more than lorazepam 2 mg daily (or equivalent); (2) monoamine oxidase inhibitors; and/or (3)bupropion due to its associated increased risk for seizures.
Description

Lorazepam U/day | Lorazepam Equivalent | Monoamine Oxidase Inhibitors | Bupropion | At risk of seizures Increased

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024002
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0024002
UMLS CUI [2,2]
C0205163
UMLS CUI [3]
C0026457
UMLS CUI [4]
C0085208
UMLS CUI [5,1]
C0582455
UMLS CUI [5,2]
C0205217
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Similar models

Eligibility Major Depressive Disorder NCT00305045

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
are voluntary and competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study (based on the maccat-cr)
boolean
C0021430 (UMLS CUI [1])
Major Depressive Disorder | Borderline Personality Disorder Absent | Antisocial Personality Disorder Absent
Item
have a structured clinical interview for dsm-iv (scid) confirmed dsm-iv diagnosis of mdd with no co-morbid borderline personality disorder and/or antisocial personality disorder, as confirmed by the structured clinical interview for dsm-iv axis ii disorders (scid-ii)
boolean
C1269683 (UMLS CUI [1])
C0006012 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0003431 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Age
Item
are between the ages of 18 and 85
boolean
C0001779 (UMLS CUI [1])
Antidepressive Agents Quantity Dosage | Disease stage Absent response to treatment | Intolerance to Antidepressive Agents Quantity
Item
have failed to achieve a clinical response to at least 2 separate antidepressant trials of sufficient dose for at least 6 weeks, according to stage ii criteria outlined by thase et al., or could not tolerate at least 2 trials of antidepressant medication
boolean
C0003289 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0699749 (UMLS CUI [2,1])
C0438286 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0003289 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
have a score greater than or equal to 22 on the 17-item ham-d
boolean
C3639712 (UMLS CUI [1])
Medical condition Unstable Major Absent | nervous system disorder Unstable Major Absent | Seizures | Cerebrovascular accident | Hypertensive disease | Diabetes Mellitus | Coronary Artery Disease | thyroid problem | Respiration Disorders | Hypersensitivity | Metallic implant Absent
Item
no major, unstable medical and/or neurological conditions, such as seizures, stroke, hypertension, diabetes, coronary artery disease, thyroid problems, respiratory illness, allergies and presence of metal implants.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0027765 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0036572 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0020538 (UMLS CUI [5])
C0011849 (UMLS CUI [6])
C1956346 (UMLS CUI [7])
C0851024 (UMLS CUI [8])
C0035204 (UMLS CUI [9])
C0020517 (UMLS CUI [10])
C3693688 (UMLS CUI [11,1])
C0332197 (UMLS CUI [11,2])
Item Group
C0680251 (UMLS CUI)
Substance Dependence | Substance Use Disorders
Item
have a history of dsm-iv substance dependence in the last 6 months, and have dsm-iv substance abuse in the last month
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Self-Injurious Behavior
Item
history of self-harm behaviour in past 6 months
boolean
C0085271 (UMLS CUI [1])
Illness Unstable Major | nervous system disorder Unstable Major | Seizures
Item
have a concomitant major, unstable medical or neurologic illness, or have had a history of seizures
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0036572 (UMLS CUI [3])
Suicidal
Item
are acutely suicidal
boolean
C0438696 (UMLS CUI [1])
Pregnancy
Item
are pregnant
boolean
C0032961 (UMLS CUI [1])
metallic device / implant
Item
have metal implants
boolean
C3693688 (UMLS CUI [1])
Lorazepam U/day | Lorazepam Equivalent | Monoamine Oxidase Inhibitors | Bupropion | At risk of seizures Increased
Item
are currently (or in the last 4 weeks) taking: (1) more than lorazepam 2 mg daily (or equivalent); (2) monoamine oxidase inhibitors; and/or (3)bupropion due to its associated increased risk for seizures.
boolean
C0024002 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0024002 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0026457 (UMLS CUI [3])
C0085208 (UMLS CUI [4])
C0582455 (UMLS CUI [5,1])
C0205217 (UMLS CUI [5,2])
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