ID

24003

Description

Treatment Response of Geriatric Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00754936

Link

https://clinicaltrials.gov/show/NCT00754936

Keywords

Versions (1)
  1. 7/21/17 7/21/17 -
Uploaded on

July 21, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Depression NCT00754936

English

Eligibility Depression NCT00754936

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00754936
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis: major depression, unipolar without psychotic features (by dsm-iv criteria)-severity of depression: a 24-item hdrs above 19 at screening and at baseline -
Description

Major Depressive Disorder Unipolar Hamilton depression rating scale (HDRS) | Psychotic feature Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0041696
UMLS CUI [1,3]
C2021166
UMLS CUI [2,1]
C0743076
UMLS CUI [2,2]
C0332197
level of executive dysfunction: two strata within each age stratum: stroop color-word scores - one half of the sample < 26, one of half ≥ 26.
Description

Executive dysfunction Level | Stroop Test

Data type

boolean

Alias
UMLS CUI [1,1]
C2748208
UMLS CUI [1,2]
C0441889
UMLS CUI [2]
C2718024
capacity to provide informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
high suicide risk, i.e. intent or plan to attempt suicide in near future
Description

High suicide risk | Suicide attempt Intent | Suicide attempt Planned

Data type

boolean

Alias
UMLS CUI [1]
C1271074
UMLS CUI [2,1]
C0038663
UMLS CUI [2,2]
C1283828
UMLS CUI [3,1]
C0038663
UMLS CUI [3,2]
C1301732
presence of any current axis i psychiatric disorder (other than unipolar major depression or specific phobias) including substance abuse (those with a history of substance abuse must be abstinent for at least 3 months prior to entry)
Description

Axis I diagnosis | Major Depressive Disorder Unipolar | Phobia, Specific | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0041696
UMLS CUI [3]
C0236801
UMLS CUI [4]
C0038586
axis ii diagnosis of antisocial personality disorder, mental retardation and pervasive developmental disorder (dsm-iv)
Description

Axis II diagnosis | Antisocial Personality Disorder | Mental Retardation | Pervasive Development Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0270288
UMLS CUI [2]
C0003431
UMLS CUI [3]
C0025362
UMLS CUI [4]
C0524528
history of psychiatric disorders such as psychotic depression, primary psychotic disorder, or bipolar spectrum disorder (bipolar disorder and hypomania are exclusions)
Description

Mental disorders | Depression, psychotic | Psychotic Disorder Primary | Bipolar Disorder | Hypomania

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0743072
UMLS CUI [3,1]
C0033975
UMLS CUI [3,2]
C0205225
UMLS CUI [4]
C0005586
UMLS CUI [5]
C0241934
cognition: mmse scores below 24 or diagnosis of dementia by dsm-iv
Description

Cognition | Mini-mental state examination | Dementia

Data type

boolean

Alias
UMLS CUI [1]
C0009240
UMLS CUI [2]
C0451306
UMLS CUI [3]
C0497327
acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal
Description

Illness | Illness Severe | Delirium | Neoplasm Metastasis | Decompensated cardiac failure | Liver Failure Decompensated | Kidney Failure Decompensated | Major surgery | Cerebrovascular accident | Myocardial Infarction | Pharmaceutical Preparations Causing Depressive disorder | Reserpine | Methyldopa | Steroids | Sympathomimetics Withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0011206
UMLS CUI [4]
C0027627
UMLS CUI [5]
C0581377
UMLS CUI [6,1]
C0085605
UMLS CUI [6,2]
C0205434
UMLS CUI [7,1]
C0035078
UMLS CUI [7,2]
C0205434
UMLS CUI [8]
C0679637
UMLS CUI [9]
C0038454
UMLS CUI [10]
C0027051
UMLS CUI [11,1]
C0013227
UMLS CUI [11,2]
C0678227
UMLS CUI [11,3]
C0011581
UMLS CUI [12]
C0035179
UMLS CUI [13]
C0025741
UMLS CUI [14]
C0038317
UMLS CUI [15,1]
C0039052
UMLS CUI [15,2]
C2349954
presence of a significant neurological disease such as parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases i.e. ms
Description

Nervous system disorder | Parkinson Disease | Epilepsy Primary | Epilepsy Secondary | Neoplasms, Intracranial | Craniocerebral Trauma Severe | Neurodegenerative Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0030567
UMLS CUI [3,1]
C0014544
UMLS CUI [3,2]
C0205225
UMLS CUI [4,1]
C0014544
UMLS CUI [4,2]
C0175668
UMLS CUI [5]
C1527390
UMLS CUI [6,1]
C0018674
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C0524851
history of failure to respond to escitalopram (lexapro) (20mg/day for 6 weeks or longer) during the current or previous depressive episodes
Description

Escitalopram | Lexapro | Depressive episode Absent response to treatment

Data type

boolean

Alias
UMLS CUI [1]
C1099456
UMLS CUI [2]
C1170371
UMLS CUI [3,1]
C0349217
UMLS CUI [3,2]
C0438286
history of intolerance to escitalopram (lexapro) or use of concomitant drugs that may provide reason to believe that escitalopram is contraindicated. active treatment with fluoxetine at the time of screening
Description

Intolerance to Escitalopram | Intolerance to Lexapro | Medical contraindication Escitalopram | Fluoxetine

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1099456
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1170371
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C1099456
UMLS CUI [4]
C0016365
patients' unwillingness or inability to gradually withdraw all other psychotropic medications (except for the following: low and stable doses of opiates and non-benzodiazepine hypnotics (e.g. zolpidem (5 or 10 mg), zaleplon (5 or 10 mg), or eszopiclone (1 or 2 mg).low and stable doses of diazepam and other anxiolytics should be tapered at screening; inability to tolerate taper is not an exclusion criteria.
Description

Psychotropic Drugs Withdraw Unwilling | Psychotropic Drugs Withdraw Unable | Opiates Low dose | Opiates Dose Stable | Sedative hypnotics (non-benzodiazepines) | zolpidem | zaleplon | Eszopiclone | Diazepam Low dose | Diazepam Dose Stable | Anti-Anxiety Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0033978
UMLS CUI [2,2]
C2349954
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0376196
UMLS CUI [3,2]
C0445550
UMLS CUI [4,1]
C0376196
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [5]
C3854290
UMLS CUI [6]
C0078839
UMLS CUI [7]
C0251504
UMLS CUI [8]
C1436328
UMLS CUI [9,1]
C0012010
UMLS CUI [9,2]
C0445550
UMLS CUI [10,1]
C0012010
UMLS CUI [10,2]
C0178602
UMLS CUI [10,3]
C0205360
UMLS CUI [11]
C0040616
inability to perform any of the adls (mai: adl subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion
Description

Performance of activities of daily living Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1821398
UMLS CUI [1,2]
C1299582
inability to speak english
Description

Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
aphasia
Description

Aphasia

Data type

boolean

Alias
UMLS CUI [1]
C0003537
Back to the top of the page

Similar models

Eligibility Depression NCT00754936

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00754936
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder Unipolar Hamilton depression rating scale (HDRS) | Psychotic feature Absent
Item
diagnosis: major depression, unipolar without psychotic features (by dsm-iv criteria)-severity of depression: a 24-item hdrs above 19 at screening and at baseline -
boolean
C1269683 (UMLS CUI [1,1])
C0041696 (UMLS CUI [1,2])
C2021166 (UMLS CUI [1,3])
C0743076 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Executive dysfunction Level | Stroop Test
Item
level of executive dysfunction: two strata within each age stratum: stroop color-word scores - one half of the sample < 26, one of half ≥ 26.
boolean
C2748208 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C2718024 (UMLS CUI [2])
Informed Consent
Item
capacity to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
High suicide risk | Suicide attempt Intent | Suicide attempt Planned
Item
high suicide risk, i.e. intent or plan to attempt suicide in near future
boolean
C1271074 (UMLS CUI [1])
C0038663 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
C0038663 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Axis I diagnosis | Major Depressive Disorder Unipolar | Phobia, Specific | Substance Use Disorders
Item
presence of any current axis i psychiatric disorder (other than unipolar major depression or specific phobias) including substance abuse (those with a history of substance abuse must be abstinent for at least 3 months prior to entry)
boolean
C0270287 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C0041696 (UMLS CUI [2,2])
C0236801 (UMLS CUI [3])
C0038586 (UMLS CUI [4])
Axis II diagnosis | Antisocial Personality Disorder | Mental Retardation | Pervasive Development Disorder
Item
axis ii diagnosis of antisocial personality disorder, mental retardation and pervasive developmental disorder (dsm-iv)
boolean
C0270288 (UMLS CUI [1])
C0003431 (UMLS CUI [2])
C0025362 (UMLS CUI [3])
C0524528 (UMLS CUI [4])
Mental disorders | Depression, psychotic | Psychotic Disorder Primary | Bipolar Disorder | Hypomania
Item
history of psychiatric disorders such as psychotic depression, primary psychotic disorder, or bipolar spectrum disorder (bipolar disorder and hypomania are exclusions)
boolean
C0004936 (UMLS CUI [1])
C0743072 (UMLS CUI [2])
C0033975 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
C0005586 (UMLS CUI [4])
C0241934 (UMLS CUI [5])
Cognition | Mini-mental state examination | Dementia
Item
cognition: mmse scores below 24 or diagnosis of dementia by dsm-iv
boolean
C0009240 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
Illness | Illness Severe | Delirium | Neoplasm Metastasis | Decompensated cardiac failure | Liver Failure Decompensated | Kidney Failure Decompensated | Major surgery | Cerebrovascular accident | Myocardial Infarction | Pharmaceutical Preparations Causing Depressive disorder | Reserpine | Methyldopa | Steroids | Sympathomimetics Withdrawal
Item
acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal
boolean
C0221423 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0011206 (UMLS CUI [3])
C0027627 (UMLS CUI [4])
C0581377 (UMLS CUI [5])
C0085605 (UMLS CUI [6,1])
C0205434 (UMLS CUI [6,2])
C0035078 (UMLS CUI [7,1])
C0205434 (UMLS CUI [7,2])
C0679637 (UMLS CUI [8])
C0038454 (UMLS CUI [9])
C0027051 (UMLS CUI [10])
C0013227 (UMLS CUI [11,1])
C0678227 (UMLS CUI [11,2])
C0011581 (UMLS CUI [11,3])
C0035179 (UMLS CUI [12])
C0025741 (UMLS CUI [13])
C0038317 (UMLS CUI [14])
C0039052 (UMLS CUI [15,1])
C2349954 (UMLS CUI [15,2])
Nervous system disorder | Parkinson Disease | Epilepsy Primary | Epilepsy Secondary | Neoplasms, Intracranial | Craniocerebral Trauma Severe | Neurodegenerative Disorders
Item
presence of a significant neurological disease such as parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases i.e. ms
boolean
C0027765 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0014544 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
C0014544 (UMLS CUI [4,1])
C0175668 (UMLS CUI [4,2])
C1527390 (UMLS CUI [5])
C0018674 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0524851 (UMLS CUI [7])
Escitalopram | Lexapro | Depressive episode Absent response to treatment
Item
history of failure to respond to escitalopram (lexapro) (20mg/day for 6 weeks or longer) during the current or previous depressive episodes
boolean
C1099456 (UMLS CUI [1])
C1170371 (UMLS CUI [2])
C0349217 (UMLS CUI [3,1])
C0438286 (UMLS CUI [3,2])
Intolerance to Escitalopram | Intolerance to Lexapro | Medical contraindication Escitalopram | Fluoxetine
Item
history of intolerance to escitalopram (lexapro) or use of concomitant drugs that may provide reason to believe that escitalopram is contraindicated. active treatment with fluoxetine at the time of screening
boolean
C1744706 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1170371 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C1099456 (UMLS CUI [3,2])
C0016365 (UMLS CUI [4])
Psychotropic Drugs Withdraw Unwilling | Psychotropic Drugs Withdraw Unable | Opiates Low dose | Opiates Dose Stable | Sedative hypnotics (non-benzodiazepines) | zolpidem | zaleplon | Eszopiclone | Diazepam Low dose | Diazepam Dose Stable | Anti-Anxiety Agents
Item
patients' unwillingness or inability to gradually withdraw all other psychotropic medications (except for the following: low and stable doses of opiates and non-benzodiazepine hypnotics (e.g. zolpidem (5 or 10 mg), zaleplon (5 or 10 mg), or eszopiclone (1 or 2 mg).low and stable doses of diazepam and other anxiolytics should be tapered at screening; inability to tolerate taper is not an exclusion criteria.
boolean
C0033978 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0033978 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0376196 (UMLS CUI [3,1])
C0445550 (UMLS CUI [3,2])
C0376196 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C3854290 (UMLS CUI [5])
C0078839 (UMLS CUI [6])
C0251504 (UMLS CUI [7])
C1436328 (UMLS CUI [8])
C0012010 (UMLS CUI [9,1])
C0445550 (UMLS CUI [9,2])
C0012010 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0205360 (UMLS CUI [10,3])
C0040616 (UMLS CUI [11])
Performance of activities of daily living Unable
Item
inability to perform any of the adls (mai: adl subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion
boolean
C1821398 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Able to speak English Language
Item
inability to speak english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Aphasia
Item
aphasia
boolean
C0003537 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial