ID

36352

Description

MRI Studies of Emotion in Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02429011

Link

https://clinicaltrials.gov/show/NCT02429011

Keywords

Versions (1)
  1. 5/6/19 5/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02429011

English

Eligibility Major Depressive Disorder NCT02429011

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female participants, 18-70 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
participants must be free of any psychiatric condition (for the healthy volunteer group) or meet dsm-iv criteria for major depressive disorder, without psychotic features, based on the structured clinical interview for dsm-iv tr axis i disorders (scid);
Description

Healthy Volunteers | Mental disorders Free of | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0332296
UMLS CUI [3]
C0743081
participants have demonstrated inadequate response to a minimum of 1 adequate antidepressant treatment trial in current episode (e.g. trd);
Description

Antidepressant therapy Response Inadequate | Antidepressant therapy Quantity Major depressive episode | Depressive Disorder, Treatment-Resistant

Data type

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C1096649
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0024517
UMLS CUI [3]
C2063866
participants must be willing to undergo washout of psychotropic medications that he or she is taking;
Description

Washout Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0033978
participants must have a level of understanding of the english language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.
Description

Comprehension Level English Language | Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C0376245
UMLS CUI [2]
C0525058
UMLS CUI [3]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
lifetime diagnosis of schizophrenia or any psychotic disorder, bipolar disorder, pervasive developmental disorders or mental retardation;
Description

Schizophrenia Lifetime | Psychotic Disorders Lifetime | Bipolar Disorder Lifetime | Pervasive Development Disorder Lifetime | Mental Retardation Lifetime

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C4071830
UMLS CUI [2,1]
C0033975
UMLS CUI [2,2]
C4071830
UMLS CUI [3,1]
C0005586
UMLS CUI [3,2]
C4071830
UMLS CUI [4,1]
C0524528
UMLS CUI [4,2]
C4071830
UMLS CUI [5,1]
C0025362
UMLS CUI [5,2]
C4071830
current diagnosis of obsessive-compulsive disorder (ocd), but not other anxiety disorders;
Description

Obsessive-Compulsive Disorder | Anxiety Disorders Other Absent

Data type

boolean

Alias
UMLS CUI [1]
C0028768
UMLS CUI [2,1]
C0003469
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0332197
diagnosis of a substance use disorder within the past six months; all participants must have a negative urine toxicology test on the day of the fmri, prior to the scan;
Description

Substance Use Disorders | Urinalysis Toxicologic Negative

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0042014
UMLS CUI [2,2]
C0205472
UMLS CUI [2,3]
C1513916
female participants who are pregnant, nursing, for may become pregnant;
Description

Pregnancy | Breast Feeding | Pregnancy possible

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0425965
any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
Description

Illness Unstable | Liver diseases | Kidney Diseases | Gastroenterology Disease | Respiration Disorders | Cardiovascular Diseases | Myocardial Ischemia | Endocrine System Diseases | Nervous system disorder | Craniocerebral Trauma Severe | Immune System Diseases | Hematological Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4,1]
C0017163
UMLS CUI [4,2]
C0012634
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0007222
UMLS CUI [7]
C0151744
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0027765
UMLS CUI [10,1]
C0018674
UMLS CUI [10,2]
C0205082
UMLS CUI [11]
C0021053
UMLS CUI [12]
C0018939
clinically significant abnormalities of laboratories, physical examination, or ecg;
Description

Laboratory test result abnormal | Physical examination abnormal | Electrocardiogram abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0747585
UMLS CUI [3]
C0522055
participants judged to be at serious suicidal risk by the pi or another study-affiliated psychiatrist;
Description

At risk for suicide Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
any contraindications to mri, including pacemakers or metallic objects in the body.
Description

Medical contraindication MRI | Artificial cardiac pacemaker | Metallic foreign body Human body

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3,1]
C1720389
UMLS CUI [3,2]
C1318419
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Similar models

Eligibility Major Depressive Disorder NCT02429011

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female participants, 18-70 years of age;
boolean
C0001779 (UMLS CUI [1])
Healthy Volunteers | Mental disorders Free of | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE
Item
participants must be free of any psychiatric condition (for the healthy volunteer group) or meet dsm-iv criteria for major depressive disorder, without psychotic features, based on the structured clinical interview for dsm-iv tr axis i disorders (scid);
boolean
C1708335 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0743081 (UMLS CUI [3])
Antidepressant therapy Response Inadequate | Antidepressant therapy Quantity Major depressive episode | Depressive Disorder, Treatment-Resistant
Item
participants have demonstrated inadequate response to a minimum of 1 adequate antidepressant treatment trial in current episode (e.g. trd);
boolean
C1096649 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C1096649 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0024517 (UMLS CUI [2,3])
C2063866 (UMLS CUI [3])
Washout Psychotropic Drugs
Item
participants must be willing to undergo washout of psychotropic medications that he or she is taking;
boolean
C1710661 (UMLS CUI [1,1])
C0033978 (UMLS CUI [1,2])
Comprehension Level English Language | Protocol Compliance | Informed Consent
Item
participants must have a level of understanding of the english language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.
boolean
C0233733 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Schizophrenia Lifetime | Psychotic Disorders Lifetime | Bipolar Disorder Lifetime | Pervasive Development Disorder Lifetime | Mental Retardation Lifetime
Item
lifetime diagnosis of schizophrenia or any psychotic disorder, bipolar disorder, pervasive developmental disorders or mental retardation;
boolean
C0036341 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0033975 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C0005586 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
C0524528 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0025362 (UMLS CUI [5,1])
C4071830 (UMLS CUI [5,2])
Obsessive-Compulsive Disorder | Anxiety Disorders Other Absent
Item
current diagnosis of obsessive-compulsive disorder (ocd), but not other anxiety disorders;
boolean
C0028768 (UMLS CUI [1])
C0003469 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Substance Use Disorders | Urinalysis Toxicologic Negative
Item
diagnosis of a substance use disorder within the past six months; all participants must have a negative urine toxicology test on the day of the fmri, prior to the scan;
boolean
C0038586 (UMLS CUI [1])
C0042014 (UMLS CUI [2,1])
C0205472 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy possible
Item
female participants who are pregnant, nursing, for may become pregnant;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0425965 (UMLS CUI [3])
Illness Unstable | Liver diseases | Kidney Diseases | Gastroenterology Disease | Respiration Disorders | Cardiovascular Diseases | Myocardial Ischemia | Endocrine System Diseases | Nervous system disorder | Craniocerebral Trauma Severe | Immune System Diseases | Hematological Disease
Item
any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0017163 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0035204 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0151744 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0018674 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0021053 (UMLS CUI [11])
C0018939 (UMLS CUI [12])
Laboratory test result abnormal | Physical examination abnormal | Electrocardiogram abnormal
Item
clinically significant abnormalities of laboratories, physical examination, or ecg;
boolean
C0438215 (UMLS CUI [1])
C0747585 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
At risk for suicide Serious
Item
participants judged to be at serious suicidal risk by the pi or another study-affiliated psychiatrist;
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Medical contraindication MRI | Artificial cardiac pacemaker | Metallic foreign body Human body
Item
any contraindications to mri, including pacemakers or metallic objects in the body.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C1720389 (UMLS CUI [3,1])
C1318419 (UMLS CUI [3,2])
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