ID

36337

Description

Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project; ODM derived from: https://clinicaltrials.gov/show/NCT02434393

Link

https://clinicaltrials.gov/show/NCT02434393

Keywords

Versions (1)
  1. 5/3/19 5/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depression NCT02434393

English

Eligibility Major Depression NCT02434393

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. current dsm-iv diagnosis of major depressive disorder, unipolar type, without psychotic features and six week minimum duration of current depressive episode.
Description

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Type Unipolar | Major depressive episode Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0743081
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0443340
UMLS CUI [2,1]
C0024517
UMLS CUI [2,2]
C0449238
2. english speaking
Description

Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
3. 65+ years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. hamilton depression rating scale score ≥ 15
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
5. able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
6. willing to undergo one mri (3 tesla) and one pet scan (amyloid imaging)
Description

MRI scan | PET scan | Amyloid Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0024485
UMLS CUI [2]
C0032743
UMLS CUI [3,1]
C0002716
UMLS CUI [3,2]
C0011923
7. able to fit in an mri machine comfortably (bmi ≤ 38)
Description

Patient Appropriate MRI Machine | Body mass index

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0024485
UMLS CUI [1,4]
C0336779
UMLS CUI [2]
C1305855
8. agrees to collection of blood for gwas, apolipoprotein e (apoe) testing and dna and rna testing
Description

Collection of blood GWAS | Collection of blood Apolipoprotein E Testing | Collection of blood DNA test | Collection of blood RNA Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2350277
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0003595
UMLS CUI [2,3]
C0039593
UMLS CUI [3,1]
C0005834
UMLS CUI [3,2]
C1658606
UMLS CUI [4,1]
C0005834
UMLS CUI [4,2]
C0035668
UMLS CUI [4,3]
C0039593
9. agrees to collection of blood for biomarker testing
Description

Collection of blood Biomarker Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C0039593
10. agrees to collection of additional blood sample for to-be-determined assays and telomere length measurement
Description

Collection of blood specimen Additional Assay | Collection of blood specimen Telomere Length Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C1510438
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C4331397
UMLS CUI [2,3]
C0242485
11. visual and auditory acuity adequate for neuropsychological testing
Description

Visual Acuity Adequate Neuropsychological Tests | Auditory acuity Adequate Neuropsychological Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C0027902
UMLS CUI [2,1]
C0679027
UMLS CUI [2,2]
C0205411
UMLS CUI [2,3]
C0027902
12. completed six grades of education or has established work history (sufficient to exclude mental retardation)
Description

Educational Status Grade | Employment history | Mental Retardation Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0013658
UMLS CUI [1,2]
C0441800
UMLS CUI [2]
C1286384
UMLS CUI [3,1]
C0025362
UMLS CUI [3,2]
C0332196
13. study partner is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), and can accompany the subject to clinical visits for the duration of the protocol.
Description

Clinical Trial Partner Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C3887537
UMLS CUI [1,3]
C0470187
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. current diagnosis of other axis 1 psychiatric disorders (with the exception of simple phobias and generalized anxiety disorder)
Description

Axis I diagnosis | Exception Simple phobia | Exception Generalized Anxiety Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0236801
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0270549
2. evidence of dementia (mmse <25)
Description

Dementia Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
3. any electroconvulsive therapy within the past 6 months
Description

Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
4. undergoing anti-depressant or psychotherapy treatment (exceptions listed 4.3. treatment exclusion exceptions)
Description

Antidepressant therapy | Psychotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1096649
UMLS CUI [2]
C0033968
5. any significant neurological diseases (i.e. parkinson's disease, epilepsy, cortical stroke, traumatic brain injury)
Description

Nervous system disorder | Parkinson Disease | Epilepsy | Stroke Cortical | Traumatic Brain Injury

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0014544
UMLS CUI [4,1]
C0038454
UMLS CUI [4,2]
C0007776
UMLS CUI [5]
C0876926
6. history of alcohol or substance abuse or dependence within the past 2 years (dsm-iv criteria)
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
7. any active and serious suicidal ideation, including ideation, plan and intent to carry out that plan, as assessed by the hamilton depression rating scale (hdrs)
Description

Feeling suicidal Serious Hamilton depression rating scale (HDRS) | Planning suicide HDRS | Suicidal intent HDRS

Data type

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2021166
UMLS CUI [2,1]
C0424001
UMLS CUI [2,2]
C2021166
UMLS CUI [3,1]
C0582496
UMLS CUI [3,2]
C2021166
8. any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
Description

Systemic disease Difficulty with Protocol Compliance | Medical condition Unstable Difficulty with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0332218
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0332218
UMLS CUI [2,4]
C0525058
9. history of surgical procedures effecting study outcomes
Description

Operative Surgical Procedures Effect Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0683954
10. residence in skilled nursing facility
Description

Residence Skilled nursing facility

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0037265
11. participation in clinical studies involving the same neuropsychological measures used in adni-d that may impact study outcomes
Description

Study Subject Participation Status | Neuropsychological Tests Impact Research results

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0027902
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0683954
12. investigational agents are prohibited one month prior to entry and for the duration of the trial
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
13. exclusion for amyloid imaging with florbetapir: current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the subject in any given year would exceed the limits of annual and total dose commitment set forth in the us code of federal regulations (cfr) title 21 section 361.1
Description

Amyloid Imaging Florbetapir

Data type

boolean

Alias
UMLS CUI [1,1]
C0002716
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C2742211
14. known history of mri scans with evidence of infection, infarction, or other focal lesions. subjects with multiple lacunes or lacunes in a critical memory structure are excluded
Description

Communicable Disease MRI Scans | Infarction MRI Scans | Lesion Focal MRI Scans | Lacune multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0917711
UMLS CUI [2,1]
C0021308
UMLS CUI [2,2]
C0917711
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0205234
UMLS CUI [3,3]
C0917711
UMLS CUI [4,1]
C0241970
UMLS CUI [4,2]
C0439064
15. presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia
Description

Artificial cardiac pacemaker | Aneurysm clip | Artificial heart valve | Implant, Middle Ear | Eye foreign bodies | Metal splinters in skin | Metallic foreign body Human body | Claustrophobia

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0179977
UMLS CUI [3]
C1399223
UMLS CUI [4]
C0086454
UMLS CUI [5]
C0015401
UMLS CUI [6]
C2229035
UMLS CUI [7,1]
C1720389
UMLS CUI [7,2]
C0242821
UMLS CUI [8]
C0008909
16. pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)
Description

Pregnancy | Breast Feeding | Childbearing Potential | Gender Postmenopausal state | Gender Female Sterilization

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0232970
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0015787
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Similar models

Eligibility Major Depression NCT02434393

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Type Unipolar | Major depressive episode Duration
Item
1. current dsm-iv diagnosis of major depressive disorder, unipolar type, without psychotic features and six week minimum duration of current depressive episode.
boolean
C0743081 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0443340 (UMLS CUI [1,3])
C0024517 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Able to speak English Language
Item
2. english speaking
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Age
Item
3. 65+ years of age
boolean
C0001779 (UMLS CUI [1])
Hamilton rating scale for depression
Item
4. hamilton depression rating scale score ≥ 15
boolean
C0451203 (UMLS CUI [1])
Informed Consent
Item
5. able to give informed consent
boolean
C0021430 (UMLS CUI [1])
MRI scan | PET scan | Amyloid Imaging
Item
6. willing to undergo one mri (3 tesla) and one pet scan (amyloid imaging)
boolean
C0024485 (UMLS CUI [1])
C0032743 (UMLS CUI [2])
C0002716 (UMLS CUI [3,1])
C0011923 (UMLS CUI [3,2])
Patient Appropriate MRI Machine | Body mass index
Item
7. able to fit in an mri machine comfortably (bmi ≤ 38)
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0336779 (UMLS CUI [1,4])
C1305855 (UMLS CUI [2])
Collection of blood GWAS | Collection of blood Apolipoprotein E Testing | Collection of blood DNA test | Collection of blood RNA Testing
Item
8. agrees to collection of blood for gwas, apolipoprotein e (apoe) testing and dna and rna testing
boolean
C0005834 (UMLS CUI [1,1])
C2350277 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0003595 (UMLS CUI [2,2])
C0039593 (UMLS CUI [2,3])
C0005834 (UMLS CUI [3,1])
C1658606 (UMLS CUI [3,2])
C0005834 (UMLS CUI [4,1])
C0035668 (UMLS CUI [4,2])
C0039593 (UMLS CUI [4,3])
Collection of blood Biomarker Testing
Item
9. agrees to collection of blood for biomarker testing
boolean
C0005834 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Collection of blood specimen Additional Assay | Collection of blood specimen Telomere Length Measurement
Item
10. agrees to collection of additional blood sample for to-be-determined assays and telomere length measurement
boolean
C0005834 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1510438 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C4331397 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
Visual Acuity Adequate Neuropsychological Tests | Auditory acuity Adequate Neuropsychological Tests
Item
11. visual and auditory acuity adequate for neuropsychological testing
boolean
C0042812 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0027902 (UMLS CUI [1,3])
C0679027 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
C0027902 (UMLS CUI [2,3])
Educational Status Grade | Employment history | Mental Retardation Excluded
Item
12. completed six grades of education or has established work history (sufficient to exclude mental retardation)
boolean
C0013658 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1286384 (UMLS CUI [2])
C0025362 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Clinical Trial Partner Available
Item
13. study partner is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), and can accompany the subject to clinical visits for the duration of the protocol.
boolean
C0008976 (UMLS CUI [1,1])
C3887537 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Exception Simple phobia | Exception Generalized Anxiety Disorder
Item
1. current diagnosis of other axis 1 psychiatric disorders (with the exception of simple phobias and generalized anxiety disorder)
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0236801 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0270549 (UMLS CUI [3,2])
Dementia Mini-mental state examination
Item
2. evidence of dementia (mmse <25)
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Electroconvulsive Therapy
Item
3. any electroconvulsive therapy within the past 6 months
boolean
C0013806 (UMLS CUI [1])
Antidepressant therapy | Psychotherapy
Item
4. undergoing anti-depressant or psychotherapy treatment (exceptions listed 4.3. treatment exclusion exceptions)
boolean
C1096649 (UMLS CUI [1])
C0033968 (UMLS CUI [2])
Nervous system disorder | Parkinson Disease | Epilepsy | Stroke Cortical | Traumatic Brain Injury
Item
5. any significant neurological diseases (i.e. parkinson's disease, epilepsy, cortical stroke, traumatic brain injury)
boolean
C0027765 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0038454 (UMLS CUI [4,1])
C0007776 (UMLS CUI [4,2])
C0876926 (UMLS CUI [5])
Substance Use Disorders | Substance Dependence
Item
6. history of alcohol or substance abuse or dependence within the past 2 years (dsm-iv criteria)
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Feeling suicidal Serious Hamilton depression rating scale (HDRS) | Planning suicide HDRS | Suicidal intent HDRS
Item
7. any active and serious suicidal ideation, including ideation, plan and intent to carry out that plan, as assessed by the hamilton depression rating scale (hdrs)
boolean
C0424000 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2021166 (UMLS CUI [1,3])
C0424001 (UMLS CUI [2,1])
C2021166 (UMLS CUI [2,2])
C0582496 (UMLS CUI [3,1])
C2021166 (UMLS CUI [3,2])
Systemic disease Difficulty with Protocol Compliance | Medical condition Unstable Difficulty with Protocol Compliance
Item
8. any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
boolean
C0442893 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
Operative Surgical Procedures Effect Research results
Item
9. history of surgical procedures effecting study outcomes
boolean
C0543467 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Residence Skilled nursing facility
Item
10. residence in skilled nursing facility
boolean
C0237096 (UMLS CUI [1,1])
C0037265 (UMLS CUI [1,2])
Study Subject Participation Status | Neuropsychological Tests Impact Research results
Item
11. participation in clinical studies involving the same neuropsychological measures used in adni-d that may impact study outcomes
boolean
C2348568 (UMLS CUI [1])
C0027902 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Investigational New Drugs
Item
12. investigational agents are prohibited one month prior to entry and for the duration of the trial
boolean
C0013230 (UMLS CUI [1])
Amyloid Imaging Florbetapir
Item
13. exclusion for amyloid imaging with florbetapir: current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the subject in any given year would exceed the limits of annual and total dose commitment set forth in the us code of federal regulations (cfr) title 21 section 361.1
boolean
C0002716 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C2742211 (UMLS CUI [1,3])
Communicable Disease MRI Scans | Infarction MRI Scans | Lesion Focal MRI Scans | Lacune multiple
Item
14. known history of mri scans with evidence of infection, infarction, or other focal lesions. subjects with multiple lacunes or lacunes in a critical memory structure are excluded
boolean
C0009450 (UMLS CUI [1,1])
C0917711 (UMLS CUI [1,2])
C0021308 (UMLS CUI [2,1])
C0917711 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0205234 (UMLS CUI [3,2])
C0917711 (UMLS CUI [3,3])
C0241970 (UMLS CUI [4,1])
C0439064 (UMLS CUI [4,2])
Artificial cardiac pacemaker | Aneurysm clip | Artificial heart valve | Implant, Middle Ear | Eye foreign bodies | Metal splinters in skin | Metallic foreign body Human body | Claustrophobia
Item
15. presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia
boolean
C0030163 (UMLS CUI [1])
C0179977 (UMLS CUI [2])
C1399223 (UMLS CUI [3])
C0086454 (UMLS CUI [4])
C0015401 (UMLS CUI [5])
C2229035 (UMLS CUI [6])
C1720389 (UMLS CUI [7,1])
C0242821 (UMLS CUI [7,2])
C0008909 (UMLS CUI [8])
Pregnancy | Breast Feeding | Childbearing Potential | Gender Postmenopausal state | Gender Female Sterilization
Item
16. pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0232970 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0015787 (UMLS CUI [5,2])
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