ID

30532

Descrição

Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT01515215

Link

https://clinicaltrials.gov/show/NCT01515215

Palavras-chave

  1. 12/06/2018 12/06/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de junho de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT01515215

Eligibility Major Depressive Disorder NCT01515215

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
voluntary and competent to consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis of mdd, as confirmed by the structured clinical interview for the dsm-iv (scid-iv)
Descrição

Major Depressive Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1269683
18 - 85 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
failed to achieve clinical response, or did not tolerate, at least 2 separate antidepressant trials of sufficient dosage for at least 6 wks
Descrição

Clinical Response failed | Intolerance to Antidepressive Agents Dosage | Antidepressant therapy Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4055223
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0003289
UMLS CUI [2,3]
C0178602
UMLS CUI [3,1]
C1096649
UMLS CUI [3,2]
C1265611
have a score of 20 or greater on the ham-d17
Descrição

Hamilton Depression Rating Scale 17 Item Clinical Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3639712
have not had an increase or initiation of any psychoactive therapy in the 4 wks prior to testing
Descrição

Absence Psychotropic Drugs Increase | Absence Initiation Psychotropic Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0033978
UMLS CUI [1,3]
C0442805
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1704686
UMLS CUI [2,3]
C0033978
if a woman of childbearing potential, must be on an effective means of birth control
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of dsm-iv confirmed diagnosis of substance dependence in the last 6 months, or substance abuse in the last month
Descrição

Substance Dependence | Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
concomitant, major, unstable medical or neurologic illness
Descrição

Comorbidity Unstable Major | Nervous system disorder Unstable Major

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
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
history of seizures
Descrição

Seizures

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036572
acutely suicidal and/or homicidal
Descrição

Suicidal | Homicidal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438696
UMLS CUI [2]
C0745031
pregnant
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
have metal implants
Descrição

Presence of metallic device / implant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3693688
history of psychosurgery
Descrição

Psychosurgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033967
co-morbid diagnosis of borderline and/or antisocial personality disorder. as confirmed by the scid for axis ii disorders (scid-ii)
Descrição

Borderline Personality Disorder Comorbid condition | Antisocial Personality Disorder Comorbid condition

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006012
UMLS CUI [1,2]
C1275743
UMLS CUI [2,1]
C0003431
UMLS CUI [2,2]
C1275743
are currently (or in the past 4 weeks) taking more than 2 mg of lorazepam, or equivalent, daily
Descrição

Lorazepam U/day | Equivalent U/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024002
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0205163
UMLS CUI [2,2]
C0456683
ect treatment in the current episode
Descrição

Electroconvulsive Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013806

Similar models

Eligibility Major Depressive Disorder NCT01515215

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
voluntary and competent to consent
boolean
C0021430 (UMLS CUI [1])
Major Depressive Disorder
Item
diagnosis of mdd, as confirmed by the structured clinical interview for the dsm-iv (scid-iv)
boolean
C1269683 (UMLS CUI [1])
Age
Item
18 - 85 years of age
boolean
C0001779 (UMLS CUI [1])
Clinical Response failed | Intolerance to Antidepressive Agents Dosage | Antidepressant therapy Quantity
Item
failed to achieve clinical response, or did not tolerate, at least 2 separate antidepressant trials of sufficient dosage for at least 6 wks
boolean
C4055223 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0003289 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1096649 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
have a score of 20 or greater on the ham-d17
boolean
C3639712 (UMLS CUI [1])
Absence Psychotropic Drugs Increase | Absence Initiation Psychotropic Drugs
Item
have not had an increase or initiation of any psychoactive therapy in the 4 wks prior to testing
boolean
C0332197 (UMLS CUI [1,1])
C0033978 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
C0033978 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods
Item
if a woman of childbearing potential, must be on an effective means of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Substance Dependence | Substance Use Disorders
Item
history of dsm-iv confirmed diagnosis of substance dependence in the last 6 months, or substance abuse in the last month
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Comorbidity Unstable Major | Nervous system disorder Unstable Major
Item
concomitant, major, unstable medical or neurologic illness
boolean
C0009488 (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])
Seizures
Item
history of seizures
boolean
C0036572 (UMLS CUI [1])
Suicidal | Homicidal
Item
acutely suicidal and/or homicidal
boolean
C0438696 (UMLS CUI [1])
C0745031 (UMLS CUI [2])
Pregnancy
Item
pregnant
boolean
C0032961 (UMLS CUI [1])
Presence of metallic device / implant
Item
have metal implants
boolean
C3693688 (UMLS CUI [1])
Psychosurgery
Item
history of psychosurgery
boolean
C0033967 (UMLS CUI [1])
Borderline Personality Disorder Comorbid condition | Antisocial Personality Disorder Comorbid condition
Item
co-morbid diagnosis of borderline and/or antisocial personality disorder. as confirmed by the scid for axis ii disorders (scid-ii)
boolean
C0006012 (UMLS CUI [1,1])
C1275743 (UMLS CUI [1,2])
C0003431 (UMLS CUI [2,1])
C1275743 (UMLS CUI [2,2])
Lorazepam U/day | Equivalent U/day
Item
are currently (or in the past 4 weeks) taking more than 2 mg of lorazepam, or equivalent, daily
boolean
C0024002 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0205163 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Electroconvulsive Therapy
Item
ect treatment in the current episode
boolean
C0013806 (UMLS CUI [1])

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