ID

35656

Description

MR Imaging Biomarkers of Disease Response to ECT (Electroconvulsive Therapy) in Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02044289

Link

https://clinicaltrials.gov/show/NCT02044289

Keywords

Versions (1)
  1. 3/14/19 3/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT02044289

English

Eligibility Depression NCT02044289

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02044289
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ages 18 and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of major depressive disorder based on the scid
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
score of 20 or more on the ham-d at enrollment
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
ability to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
referral for ect, clinical assessment (health screening, i.e. "work-up") confirming suitability of receiving ect, and consent to receive ect
Description

Referral for Electroconvulsive Therapy | Clinical assessment Electroconvulsive Therapy Suitable | Consent Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C0013806
UMLS CUI [2,1]
C4534461
UMLS CUI [2,2]
C0013806
UMLS CUI [2,3]
C3900053
UMLS CUI [3,1]
C1511481
UMLS CUI [3,2]
C0013806
ability to speak english (necessary for scid) and an 8th grade english reading equivalency (necessary for completing assessment forms)
Description

Able to speak English Language | Able to read English Language Grade Level

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [2,3]
C0870612
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
claustrophobia, or the inability to lie still in a confined space
Description

Claustrophobia | Lacking Able to lie down Quiet Confined Space

Data type

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0560841
UMLS CUI [2,3]
C0439654
UMLS CUI [2,4]
C0600566
magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents), as these may heat, pull, or twist in the strong magnetic field of the mri scanner
Description

Implants Magnetic Metallic | Screw | Medical pins | Shrapnel | Aneurysm clip | Artificial heart valve | Cochlear Implants | Artificial joints | Vascular stent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0563532
UMLS CUI [1,3]
C2986473
UMLS CUI [2]
C0301559
UMLS CUI [3]
C0175718
UMLS CUI [4]
C0522670
UMLS CUI [5]
C0179977
UMLS CUI [6]
C1399223
UMLS CUI [7]
C0009199
UMLS CUI [8]
C3815857
UMLS CUI [9]
C0183521
electronic or magnetic implants, such as pacemakers, as these may stop working
Description

Implants Electronic | Implants Magnetic | Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0013850
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C0563532
UMLS CUI [3]
C0030163
non-removable dental implants, such as braces or permanent retainers, as these will distort the mri images we collect (note: filings, crowns, and silver or gold teeth are ok)
Description

Dental implants | Removal Unsuccessful | Dental brace | Retainer Dental Permanent

Data type

boolean

Alias
UMLS CUI [1]
C0011373
UMLS CUI [2,1]
C1883720
UMLS CUI [2,2]
C1272705
UMLS CUI [3]
C0743050
UMLS CUI [4,1]
C0183009
UMLS CUI [4,2]
C0226984
UMLS CUI [4,3]
C0205355
permanent makeup or tattoos with metallic dyes
Description

Makeup Permanent | Tattoo dye Metallic

Data type

boolean

Alias
UMLS CUI [1,1]
C1998591
UMLS CUI [1,2]
C0205355
UMLS CUI [2,1]
C0303923
UMLS CUI [2,2]
C2986473
self-report of pregnancy at intake
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
a positive pregnancy test (for females), since the effect of strong magnetic fields on the developing fetus remains unknown and inconclusive. (we will conduct a pregnancy test for all female participants on the day of the mri scan.)
Description

Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0240802
a self-reported history of loss of consciousness (greater than 10 minutes)
Description

Unconscious State Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0041657
UMLS CUI [1,2]
C0449238
physical disabilities that prohibit task performance (such as blindness or deafness)
Description

Physical disability Preventing Task Performance | Blindness | Deafness

Data type

boolean

Alias
UMLS CUI [1,1]
C0520817
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0039333
UMLS CUI [2]
C0456909
UMLS CUI [3]
C0011053
any other condition that the investigator believes might put the participant at risk
Description

Condition Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
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Similar models

Eligibility Depression NCT02044289

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02044289
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ages 18 and older
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
diagnosis of major depressive disorder based on the scid
boolean
C1269683 (UMLS CUI [1])
Hamilton rating scale for depression
Item
score of 20 or more on the ham-d at enrollment
boolean
C0451203 (UMLS CUI [1])
Informed Consent
Item
ability to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Referral for Electroconvulsive Therapy | Clinical assessment Electroconvulsive Therapy Suitable | Consent Electroconvulsive Therapy
Item
referral for ect, clinical assessment (health screening, i.e. "work-up") confirming suitability of receiving ect, and consent to receive ect
boolean
C2585524 (UMLS CUI [1,1])
C0013806 (UMLS CUI [1,2])
C4534461 (UMLS CUI [2,1])
C0013806 (UMLS CUI [2,2])
C3900053 (UMLS CUI [2,3])
C1511481 (UMLS CUI [3,1])
C0013806 (UMLS CUI [3,2])
Able to speak English Language | Able to read English Language Grade Level
Item
ability to speak english (necessary for scid) and an 8th grade english reading equivalency (necessary for completing assessment forms)
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0870612 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Claustrophobia | Lacking Able to lie down Quiet Confined Space
Item
claustrophobia, or the inability to lie still in a confined space
boolean
C0008909 (UMLS CUI [1])
C0332268 (UMLS CUI [2,1])
C0560841 (UMLS CUI [2,2])
C0439654 (UMLS CUI [2,3])
C0600566 (UMLS CUI [2,4])
Implants Magnetic Metallic | Screw | Medical pins | Shrapnel | Aneurysm clip | Artificial heart valve | Cochlear Implants | Artificial joints | Vascular stent
Item
magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents), as these may heat, pull, or twist in the strong magnetic field of the mri scanner
boolean
C0021102 (UMLS CUI [1,1])
C0563532 (UMLS CUI [1,2])
C2986473 (UMLS CUI [1,3])
C0301559 (UMLS CUI [2])
C0175718 (UMLS CUI [3])
C0522670 (UMLS CUI [4])
C0179977 (UMLS CUI [5])
C1399223 (UMLS CUI [6])
C0009199 (UMLS CUI [7])
C3815857 (UMLS CUI [8])
C0183521 (UMLS CUI [9])
Implants Electronic | Implants Magnetic | Artificial cardiac pacemaker
Item
electronic or magnetic implants, such as pacemakers, as these may stop working
boolean
C0021102 (UMLS CUI [1,1])
C0013850 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2,1])
C0563532 (UMLS CUI [2,2])
C0030163 (UMLS CUI [3])
Dental implants | Removal Unsuccessful | Dental brace | Retainer Dental Permanent
Item
non-removable dental implants, such as braces or permanent retainers, as these will distort the mri images we collect (note: filings, crowns, and silver or gold teeth are ok)
boolean
C0011373 (UMLS CUI [1])
C1883720 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0743050 (UMLS CUI [3])
C0183009 (UMLS CUI [4,1])
C0226984 (UMLS CUI [4,2])
C0205355 (UMLS CUI [4,3])
Makeup Permanent | Tattoo dye Metallic
Item
permanent makeup or tattoos with metallic dyes
boolean
C1998591 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C0303923 (UMLS CUI [2,1])
C2986473 (UMLS CUI [2,2])
Pregnancy
Item
self-report of pregnancy at intake
boolean
C0032961 (UMLS CUI [1])
Pregnancy test positive
Item
a positive pregnancy test (for females), since the effect of strong magnetic fields on the developing fetus remains unknown and inconclusive. (we will conduct a pregnancy test for all female participants on the day of the mri scan.)
boolean
C0240802 (UMLS CUI [1])
Unconscious State Duration
Item
a self-reported history of loss of consciousness (greater than 10 minutes)
boolean
C0041657 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Physical disability Preventing Task Performance | Blindness | Deafness
Item
physical disabilities that prohibit task performance (such as blindness or deafness)
boolean
C0520817 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0039333 (UMLS CUI [1,3])
C0456909 (UMLS CUI [2])
C0011053 (UMLS CUI [3])
Condition Study Subject Participation Status At risk
Item
any other condition that the investigator believes might put the participant at risk
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
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