ID

28855

Beskrivning

Cymbalta for Depression as a Complication of Bereavement; ODM derived from: https://clinicaltrials.gov/show/NCT00658931

Länk

https://clinicaltrials.gov/show/NCT00658931

Nyckelord

Versioner (1)
  1. 2018-02-08 2018-02-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depression NCT00658931

Engelsk

Eligibility Depression NCT00658931

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00658931
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have sustained the loss of a first-degree relative (spouse, partner, child, parent, sibling, or person otherwise described by the patient as a first-degree relative) within the past two years and one of the two following features must also be present:
Beskrivning

Death First Degree Relative | Death Spouse | Death Partner | Death Child | Death Parent | Death Sibling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1306577
UMLS CUI [1,2]
C1517194
UMLS CUI [2,1]
C1306577
UMLS CUI [2,2]
C0162409
UMLS CUI [3,1]
C1306577
UMLS CUI [3,2]
C0682323
UMLS CUI [4,1]
C1306577
UMLS CUI [4,2]
C0680063
UMLS CUI [5,1]
C1306577
UMLS CUI [5,2]
C0030551
UMLS CUI [6,1]
C1306577
UMLS CUI [6,2]
C0037047
1. at least two months must have passed since the death prior to enrollment in the study, or
Beskrivning

Elapsed Time Since Death

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2826303
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C1306577
2. there must be evidence of marked functional impairment (as defined in the dsm-iv description of bereavement, v62.82);
Beskrivning

Functional impairment Marked

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4062321
UMLS CUI [1,2]
C1706089
must meet criteria for a major depressive episode as defined in dsm-iv;
Beskrivning

Major depressive episode Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
onset of this depressive episode must have occurred after the death of the first-degree relative (if the relative's death was unexpected) or no more then three months prior to the death of the relative (if the relative's death was expected);
Beskrivning

Major depressive episode Onset | Status post Death First Degree Relative | Status pre- Death First Degree Relative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0332162
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1306577
UMLS CUI [2,3]
C1517194
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C1306577
UMLS CUI [3,3]
C1517194
hrsd-17 score of >17 at baseline assessment;
Beskrivning

Hamilton Depression Rating Scale 17 Item Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
must be in stable medical health;
Beskrivning

Health Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018684
UMLS CUI [1,2]
C0205360
must be able to communicate in english; and
Beskrivning

Able to communicate English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0376245
must be willing and able to travel to the cooper green mercy hospital or the jefferson clinic, pc for evaluations according to the study protocol.
Beskrivning

Travel Clinic Able | Travel Clinic Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0040802
UMLS CUI [2,2]
C0442592
UMLS CUI [2,3]
C0600109
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of dysthymic disorder or a depressive episode preceding the death of the first-degree relative by more than three months;
Beskrivning

Dysthymic Disorder | Depressive episode Preceding Death First Degree Relative

Datatyp

boolean

Alias
UMLS CUI [1]
C0013415
UMLS CUI [2,1]
C0349217
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C1306577
UMLS CUI [2,4]
C1517194
history or symptoms of mania or psychosis (e.g., bipolar disorders, schizophrenia and other psychotic disorders);
Beskrivning

Mania | Psychotic Disorders | Symptoms Mania | Symptoms Psychotic Disorders | Bipolar Disorder | Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0338831
UMLS CUI [2]
C0033975
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0338831
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0033975
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0036341
evidence of current alcohol or other substance abuse or dependence;
Beskrivning

Substance Use Disorders | Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
evidence of clinically significant dementia or cognitive impairment (from history or a score on the screening mini mental state exam of 23 or less);
Beskrivning

Dementia | Impaired cognition Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0451306
concomitant use of other antidepressants (patients can be enrolled after taper and clearance of other antidepressant medications);
Beskrivning

Antidepressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003289
concomitant use of medications known to have potential for clinically significant interaction with cymbalta (patients can be enrolled after taper and clearance of other medications, if other medications can be safely discontinued).
Beskrivning

Pharmaceutical Preparations Interaction Cymbalta

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C1505021
suicidal thoughts with intent or plan, or other situations where the patient is judged to be a high risk of suicide;
Beskrivning

Feeling suicidal | Suicidal intent | Planning suicide | High suicide risk

Datatyp

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0582496
UMLS CUI [3]
C0424001
UMLS CUI [4]
C1271074
known hypersensitivity to cymbalta or any of its inactive ingredients;
Beskrivning

Hypersensitivity Cymbalta | Hypersensitivity Cymbalta Inactive ingredient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1505021
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1505021
UMLS CUI [2,3]
C1552019
treatment with a monoamine oxidase inhibitor (maoi) within 14 days of randomization or potential need to use an maoi during the study or within 5 days of discontinuation of study drug; or
Beskrivning

Monoamine Oxidase Inhibitors | Patient need for Monoamine Oxidase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0026457
any of the following medical conditions present:
Beskrivning

Medical condition Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1552551
1. hepatic impairment or insufficiency,
Beskrivning

Hepatic impairment | Hepatic Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1306571
2. hyponatremia,
Beskrivning

Hyponatremia

Datatyp

boolean

Alias
UMLS CUI [1]
C0020625
3. narrow-angle glaucoma,
Beskrivning

Angle Closure Glaucoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0017605
4. history of seizures,
Beskrivning

Seizures

Datatyp

boolean

Alias
UMLS CUI [1]
C0036572
5. unstable hypertension, or
Beskrivning

Hypertensive disease Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0443343
6. pregnancy.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Depression NCT00658931

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00658931
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Death First Degree Relative | Death Spouse | Death Partner | Death Child | Death Parent | Death Sibling
Item
must have sustained the loss of a first-degree relative (spouse, partner, child, parent, sibling, or person otherwise described by the patient as a first-degree relative) within the past two years and one of the two following features must also be present:
boolean
C1306577 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
C1306577 (UMLS CUI [2,1])
C0162409 (UMLS CUI [2,2])
C1306577 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C1306577 (UMLS CUI [4,1])
C0680063 (UMLS CUI [4,2])
C1306577 (UMLS CUI [5,1])
C0030551 (UMLS CUI [5,2])
C1306577 (UMLS CUI [6,1])
C0037047 (UMLS CUI [6,2])
Elapsed Time Since Death
Item
1. at least two months must have passed since the death prior to enrollment in the study, or
boolean
C2826303 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C1306577 (UMLS CUI [1,3])
Functional impairment Marked
Item
2. there must be evidence of marked functional impairment (as defined in the dsm-iv description of bereavement, v62.82);
boolean
C4062321 (UMLS CUI [1,1])
C1706089 (UMLS CUI [1,2])
Major depressive episode Criteria Fulfill
Item
must meet criteria for a major depressive episode as defined in dsm-iv;
boolean
C0024517 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Major depressive episode Onset | Status post Death First Degree Relative | Status pre- Death First Degree Relative
Item
onset of this depressive episode must have occurred after the death of the first-degree relative (if the relative's death was unexpected) or no more then three months prior to the death of the relative (if the relative's death was expected);
boolean
C0024517 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1306577 (UMLS CUI [2,2])
C1517194 (UMLS CUI [2,3])
C0332152 (UMLS CUI [3,1])
C1306577 (UMLS CUI [3,2])
C1517194 (UMLS CUI [3,3])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
hrsd-17 score of >17 at baseline assessment;
boolean
C3639712 (UMLS CUI [1])
Health Stable
Item
must be in stable medical health;
boolean
C0018684 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Able to communicate English Language
Item
must be able to communicate in english; and
boolean
C2364293 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Travel Clinic Able | Travel Clinic Willing
Item
must be willing and able to travel to the cooper green mercy hospital or the jefferson clinic, pc for evaluations according to the study protocol.
boolean
C0040802 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0040802 (UMLS CUI [2,1])
C0442592 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Dysthymic Disorder | Depressive episode Preceding Death First Degree Relative
Item
history of dysthymic disorder or a depressive episode preceding the death of the first-degree relative by more than three months;
boolean
C0013415 (UMLS CUI [1])
C0349217 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C1306577 (UMLS CUI [2,3])
C1517194 (UMLS CUI [2,4])
Mania | Psychotic Disorders | Symptoms Mania | Symptoms Psychotic Disorders | Bipolar Disorder | Schizophrenia
Item
history or symptoms of mania or psychosis (e.g., bipolar disorders, schizophrenia and other psychotic disorders);
boolean
C0338831 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0338831 (UMLS CUI [3,2])
C1457887 (UMLS CUI [4,1])
C0033975 (UMLS CUI [4,2])
C0005586 (UMLS CUI [5])
C0036341 (UMLS CUI [6])
Substance Use Disorders | Substance Dependence
Item
evidence of current alcohol or other substance abuse or dependence;
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Dementia | Impaired cognition Mini-mental state examination
Item
evidence of clinically significant dementia or cognitive impairment (from history or a score on the screening mini mental state exam of 23 or less);
boolean
C0497327 (UMLS CUI [1])
C0338656 (UMLS CUI [2,1])
C0451306 (UMLS CUI [2,2])
Antidepressive Agents
Item
concomitant use of other antidepressants (patients can be enrolled after taper and clearance of other antidepressant medications);
boolean
C0003289 (UMLS CUI [1])
Pharmaceutical Preparations Interaction Cymbalta
Item
concomitant use of medications known to have potential for clinically significant interaction with cymbalta (patients can be enrolled after taper and clearance of other medications, if other medications can be safely discontinued).
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C1505021 (UMLS CUI [1,3])
Feeling suicidal | Suicidal intent | Planning suicide | High suicide risk
Item
suicidal thoughts with intent or plan, or other situations where the patient is judged to be a high risk of suicide;
boolean
C0424000 (UMLS CUI [1])
C0582496 (UMLS CUI [2])
C0424001 (UMLS CUI [3])
C1271074 (UMLS CUI [4])
Hypersensitivity Cymbalta | Hypersensitivity Cymbalta Inactive ingredient
Item
known hypersensitivity to cymbalta or any of its inactive ingredients;
boolean
C0020517 (UMLS CUI [1,1])
C1505021 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1505021 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
Monoamine Oxidase Inhibitors | Patient need for Monoamine Oxidase Inhibitors
Item
treatment with a monoamine oxidase inhibitor (maoi) within 14 days of randomization or potential need to use an maoi during the study or within 5 days of discontinuation of study drug; or
boolean
C0026457 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0026457 (UMLS CUI [2,2])
Medical condition Any
Item
any of the following medical conditions present:
boolean
C3843040 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Hepatic impairment | Hepatic Insufficiency
Item
1. hepatic impairment or insufficiency,
boolean
C0948807 (UMLS CUI [1])
C1306571 (UMLS CUI [2])
Hyponatremia
Item
2. hyponatremia,
boolean
C0020625 (UMLS CUI [1])
Angle Closure Glaucoma
Item
3. narrow-angle glaucoma,
boolean
C0017605 (UMLS CUI [1])
Seizures
Item
4. history of seizures,
boolean
C0036572 (UMLS CUI [1])
Hypertensive disease Unstable
Item
5. unstable hypertension, or
boolean
C0020538 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Pregnancy
Item
6. pregnancy.
boolean
C0032961 (UMLS CUI [1])
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