ID

28885

Beskrivning

Incomplete Response in Late Life Depression: Getting to Remission (IRL GREY); ODM derived from: https://clinicaltrials.gov/show/NCT00892047

Länk

https://clinicaltrials.gov/show/NCT00892047

Nyckelord

Versioner (1)
  1. 2018-02-10 2018-02-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depression NCT00892047

Engelsk

Eligibility Depression NCT00892047

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00892047
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age > 60 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. major depressive disorder (mdd), single or recurrent, as diagnosed by the scid-iv.
Beskrivning

Major Depressive Disorder | Single major depressive episode | Recurrent major depressive episodes

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0024517
UMLS CUI [3]
C0154409
3. madrs ≥ 15.
Beskrivning

Montgomery-Asberg Depression Rating Scale Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C4054475
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inability to provide informed consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
2. depressive symptoms not severe enough (i.e., madrs < 15) at the baseline assessments.
Beskrivning

Depressive Symptoms Montgomery-Asberg Depression Rating Scale Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C4054475
3. dementia based upon dsm-iv criteria as well as a folstein mmse score of less than 24. patients screened out due to dementia will be referred to a memory clinic or to the upmc alzheimer's disease research center for evaluation to clarify the presence or absence of a dementia.
Beskrivning

Dementia Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
4. lifetime diagnosis of bipolar i or ii disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms, as diagnosed by the scid. a recommendation for psychiatric referral will be made in these cases.
Beskrivning

Bipolar I disorder Lifetime | Bipolar II disorder Lifetime | Schizophrenia | Schizoaffective Disorder | Schizophreniform Disorders | Delusional disorder | Psychotic symptom

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853193
UMLS CUI [1,2]
C4071830
UMLS CUI [2,1]
C0236788
UMLS CUI [2,2]
C4071830
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0036358
UMLS CUI [6]
C0011251
UMLS CUI [7]
C0871189
5. abuse of or dependence on alcohol or other substances within the past 3 months as determined by scid, and confirmed by study physician interview.
Beskrivning

Substance Use Disorders | Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
6. high risk for suicide (e.g., active si and/or current/recent intent or plan) and unable to be managed safely in the clinical trial (e.g., unwilling to be hospitalized). urgent psychiatric referral will be made in these cases.
Beskrivning

High suicide risk | Suicidal intent | Planning suicide | Hospitalization Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C1271074
UMLS CUI [2]
C0582496
UMLS CUI [3]
C0424001
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0558080
7. contraindication to venlafaxine xr or aripiprazole as determined by study physician including history of intolerance of either venlafaxine xr or aripiprazole in the study target dosage range (venlafaxine xr at up to 225 mg/day; aripiprazole at up to 15mg/day).
Beskrivning

Contraindication Venlafaxine | Contraindication Aripiprazole | Intolerance to Venlafaxine Dosage Range | Intolerance to Aripiprazole Dosage Range

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0078569
UMLS CUI [2,1]
C0522473
UMLS CUI [2,2]
C0299792
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0078569
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C1514721
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0299792
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C1514721
8. failure to respond to at least 6 weeks of venlafaxine (>225 mg/d) plus aripiprazole (>10 mg/d).
Beskrivning

Venlafaxine Dosage | Aripiprazole Dosage | Disease Response failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0078569
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0299792
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C0231175
9. inability to communicate in english (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in english).
Beskrivning

Lacking Able to communicate English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [1,3]
C0376245
10. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
Beskrivning

Hypesthesia | Hearing impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C0020580
UMLS CUI [2]
C1384666
11. unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management. this will be determined based on information from the patient's personal physician's and study physician clinical judgment. referral to the patient's personal physician or to a general practitioner will be made in these cases.
Beskrivning

Disease Unstable | Delirium | Diabetic - poor control | Hypertensive disease | Hyperlipidemia | Risk factors Cerebrovascular | Cardiovascular risk factor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0011206
UMLS CUI [3]
C0421258
UMLS CUI [4]
C0020538
UMLS CUI [5]
C0020473
UMLS CUI [6,1]
C0035648
UMLS CUI [6,2]
C1880018
UMLS CUI [7]
C0850624
12. subjects taking psychotropic medications that cannot be safely tapered or discontinued prior to study initiation: this would include patients on monoamine oxidase inhibitors (maoi) who would need to be off the maoi for 14 days to be eligible for the study to avoid adverse drug interactions. patients will not be allowed to take antidepressant or atypical antipsychotic medication other than the study medication, unless it is a low dose antidepressant prescribed for chronic pain that would not be medically advisable to stop (e.g., amitryptyline 50mg). if a patient's depression is adequately treated on his/her psychotropic medication, he/she would not be eligible for the study. if a patient failed a trial of venlafaxine (12 weeks of treatment with venlafaxine including at least 6 weeks on 300mg/day), he/she would not be eligible. the following are allowed: benzodiazepines up to 2mg/d lorazepam equivalent; other sedative-hypnotics (e.g., zolpidem, zaleplon, eszopiclone); gabapentin if prescribed for non-psychiatric indication (e.g., neuropathy). except for maois, there is really no clinical rationale to exclude patients on specific concomitant medications unless they are medically unstable (in which case they are excluded from participation). as noted, patients on an maoi would need to be off the maoi for 14 days to protect from adverse drug interactions.
Beskrivning

Psychotropic Drugs Discontinuation Unsuccessful | Monoamine Oxidase Inhibitors To be stopped | Antidepressive Agents | Atypical antipsychotic | Exception Amitriptyline Low dose | Venlafaxine Therapeutic procedure failed | Benzodiazepines allowed | Lorazepam Equivalent allowed | Sedative-hypnotics allowed | Zolpidem allowed | Zaleplon allowed | Eszopiclone allowed | Gabapentin Indication Neuropathy allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0026457
UMLS CUI [2,2]
C1272691
UMLS CUI [3]
C0003289
UMLS CUI [4]
C1276996
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0002600
UMLS CUI [5,3]
C0445550
UMLS CUI [6,1]
C0078569
UMLS CUI [6,2]
C0087111
UMLS CUI [6,3]
C0231175
UMLS CUI [7,1]
C0005064
UMLS CUI [7,2]
C0683607
UMLS CUI [8,1]
C0024002
UMLS CUI [8,2]
C0205163
UMLS CUI [8,3]
C0683607
UMLS CUI [9,1]
C0020592
UMLS CUI [9,2]
C0683607
UMLS CUI [10,1]
C0078839
UMLS CUI [10,2]
C0683607
UMLS CUI [11,1]
C0251504
UMLS CUI [11,2]
C0683607
UMLS CUI [12,1]
C1436328
UMLS CUI [12,2]
C0683607
UMLS CUI [13,1]
C0060926
UMLS CUI [13,2]
C3146298
UMLS CUI [13,3]
C0442874
UMLS CUI [13,4]
C0683607
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Similar models

Eligibility Depression NCT00892047

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00892047
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age > 60 years.
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder | Single major depressive episode | Recurrent major depressive episodes
Item
2. major depressive disorder (mdd), single or recurrent, as diagnosed by the scid-iv.
boolean
C1269683 (UMLS CUI [1])
C0024517 (UMLS CUI [2])
C0154409 (UMLS CUI [3])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
3. madrs ≥ 15.
boolean
C4054475 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
1. inability to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Depressive Symptoms Montgomery-Asberg Depression Rating Scale Questionnaire
Item
2. depressive symptoms not severe enough (i.e., madrs < 15) at the baseline assessments.
boolean
C0086132 (UMLS CUI [1,1])
C4054475 (UMLS CUI [1,2])
Dementia Mini-mental state examination
Item
3. dementia based upon dsm-iv criteria as well as a folstein mmse score of less than 24. patients screened out due to dementia will be referred to a memory clinic or to the upmc alzheimer's disease research center for evaluation to clarify the presence or absence of a dementia.
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Bipolar I disorder Lifetime | Bipolar II disorder Lifetime | Schizophrenia | Schizoaffective Disorder | Schizophreniform Disorders | Delusional disorder | Psychotic symptom
Item
4. lifetime diagnosis of bipolar i or ii disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms, as diagnosed by the scid. a recommendation for psychiatric referral will be made in these cases.
boolean
C0853193 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0236788 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0036358 (UMLS CUI [5])
C0011251 (UMLS CUI [6])
C0871189 (UMLS CUI [7])
Substance Use Disorders | Substance Dependence
Item
5. abuse of or dependence on alcohol or other substances within the past 3 months as determined by scid, and confirmed by study physician interview.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
High suicide risk | Suicidal intent | Planning suicide | Hospitalization Unwilling
Item
6. high risk for suicide (e.g., active si and/or current/recent intent or plan) and unable to be managed safely in the clinical trial (e.g., unwilling to be hospitalized). urgent psychiatric referral will be made in these cases.
boolean
C1271074 (UMLS CUI [1])
C0582496 (UMLS CUI [2])
C0424001 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Contraindication Venlafaxine | Contraindication Aripiprazole | Intolerance to Venlafaxine Dosage Range | Intolerance to Aripiprazole Dosage Range
Item
7. contraindication to venlafaxine xr or aripiprazole as determined by study physician including history of intolerance of either venlafaxine xr or aripiprazole in the study target dosage range (venlafaxine xr at up to 225 mg/day; aripiprazole at up to 15mg/day).
boolean
C0522473 (UMLS CUI [1,1])
C0078569 (UMLS CUI [1,2])
C0522473 (UMLS CUI [2,1])
C0299792 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0078569 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C1514721 (UMLS CUI [3,4])
C1744706 (UMLS CUI [4,1])
C0299792 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C1514721 (UMLS CUI [4,4])
Venlafaxine Dosage | Aripiprazole Dosage | Disease Response failed
Item
8. failure to respond to at least 6 weeks of venlafaxine (>225 mg/d) plus aripiprazole (>10 mg/d).
boolean
C0078569 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0299792 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1704632 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
Lacking Able to communicate English Language
Item
9. inability to communicate in english (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in english).
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Hypesthesia | Hearing impairment
Item
10. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
boolean
C0020580 (UMLS CUI [1])
C1384666 (UMLS CUI [2])
Disease Unstable | Delirium | Diabetic - poor control | Hypertensive disease | Hyperlipidemia | Risk factors Cerebrovascular | Cardiovascular risk factor
Item
11. unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management. this will be determined based on information from the patient's personal physician's and study physician clinical judgment. referral to the patient's personal physician or to a general practitioner will be made in these cases.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0011206 (UMLS CUI [2])
C0421258 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
C0020473 (UMLS CUI [5])
C0035648 (UMLS CUI [6,1])
C1880018 (UMLS CUI [6,2])
C0850624 (UMLS CUI [7])
Psychotropic Drugs Discontinuation Unsuccessful | Monoamine Oxidase Inhibitors To be stopped | Antidepressive Agents | Atypical antipsychotic | Exception Amitriptyline Low dose | Venlafaxine Therapeutic procedure failed | Benzodiazepines allowed | Lorazepam Equivalent allowed | Sedative-hypnotics allowed | Zolpidem allowed | Zaleplon allowed | Eszopiclone allowed | Gabapentin Indication Neuropathy allowed
Item
12. subjects taking psychotropic medications that cannot be safely tapered or discontinued prior to study initiation: this would include patients on monoamine oxidase inhibitors (maoi) who would need to be off the maoi for 14 days to be eligible for the study to avoid adverse drug interactions. patients will not be allowed to take antidepressant or atypical antipsychotic medication other than the study medication, unless it is a low dose antidepressant prescribed for chronic pain that would not be medically advisable to stop (e.g., amitryptyline 50mg). if a patient's depression is adequately treated on his/her psychotropic medication, he/she would not be eligible for the study. if a patient failed a trial of venlafaxine (12 weeks of treatment with venlafaxine including at least 6 weeks on 300mg/day), he/she would not be eligible. the following are allowed: benzodiazepines up to 2mg/d lorazepam equivalent; other sedative-hypnotics (e.g., zolpidem, zaleplon, eszopiclone); gabapentin if prescribed for non-psychiatric indication (e.g., neuropathy). except for maois, there is really no clinical rationale to exclude patients on specific concomitant medications unless they are medically unstable (in which case they are excluded from participation). as noted, patients on an maoi would need to be off the maoi for 14 days to protect from adverse drug interactions.
boolean
C0033978 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0026457 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0003289 (UMLS CUI [3])
C1276996 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0002600 (UMLS CUI [5,2])
C0445550 (UMLS CUI [5,3])
C0078569 (UMLS CUI [6,1])
C0087111 (UMLS CUI [6,2])
C0231175 (UMLS CUI [6,3])
C0005064 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
C0024002 (UMLS CUI [8,1])
C0205163 (UMLS CUI [8,2])
C0683607 (UMLS CUI [8,3])
C0020592 (UMLS CUI [9,1])
C0683607 (UMLS CUI [9,2])
C0078839 (UMLS CUI [10,1])
C0683607 (UMLS CUI [10,2])
C0251504 (UMLS CUI [11,1])
C0683607 (UMLS CUI [11,2])
C1436328 (UMLS CUI [12,1])
C0683607 (UMLS CUI [12,2])
C0060926 (UMLS CUI [13,1])
C3146298 (UMLS CUI [13,2])
C0442874 (UMLS CUI [13,3])
C0683607 (UMLS CUI [13,4])
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