ID

30532

Description

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

Link

https://clinicaltrials.gov/show/NCT01515215

Keywords

Versions (1)
  1. 6/12/18 6/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT01515215

English

Eligibility Major Depressive Disorder NCT01515215

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
voluntary and competent to consent
Description

Informed Consent

Data type

boolean

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

Major Depressive Disorder

Data type

boolean

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

Age

Data type

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
Description

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

Data type

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
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification

Data type

boolean

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

Absence Psychotropic Drugs Increase | Absence Initiation Psychotropic Drugs

Data type

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
Description

Childbearing Potential Contraceptive methods

Data type

boolean

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

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
Description

Substance Dependence | Substance Use Disorders

Data type

boolean

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

Comorbidity Unstable Major | Nervous system disorder Unstable Major

Data type

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
Description

Seizures

Data type

boolean

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

Suicidal | Homicidal

Data type

boolean

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

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
have metal implants
Description

Presence of metallic device / implant

Data type

boolean

Alias
UMLS CUI [1]
C3693688
history of psychosurgery
Description

Psychosurgery

Data type

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)
Description

Borderline Personality Disorder Comorbid condition | Antisocial Personality Disorder Comorbid condition

Data type

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
Description

Lorazepam U/day | Equivalent U/day

Data type

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
Description

Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
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Similar models

Eligibility Major Depressive Disorder NCT01515215

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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