ID

36346

Beskrivning

Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine; ODM derived from: https://clinicaltrials.gov/show/NCT02263248

Länk

https://clinicaltrials.gov/show/NCT02263248

Nyckelord

Versioner (2)
  1. 2019-05-05 2019-05-05 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02263248

Engelsk

Eligibility Major Depressive Disorder NCT02263248

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age > 50 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. major depressive disorder (mdd), single or recurrent, as diagnosed by the scid-iv (or scid-5 if available)
Beskrivning

Major Depressive Disorder | Major Depressive Disorder Recurrent

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C2945760
3. madrs > 15
Beskrivning

Montgomery-Asberg Depression Rating Scale Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C4054475
4. has or agrees to establish a clinical relationship with primary care physician (pcp).
Beskrivning

Relationship Clinical Primary Care Physician

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0033131
5. availability of an informant (e.g., emergency contact) is encouraged but not required for study participation
Beskrivning

Availability of Informant | Availability of Emergency contact

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1550484
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1552023
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 Negligible MADRS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C0332269
UMLS CUI [1,3]
C4054475
3. dementia, as defined by 3ms < 80 and clinical evidence of dementia
Beskrivning

Dementia

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
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
Beskrivning

Bipolar I disorder Lifetime | Bipolar II disorder Lifetime | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime | Schizophreniform Disorders Lifetime | Delusional disorder Lifetime | 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 [3,1]
C0036341
UMLS CUI [3,2]
C4071830
UMLS CUI [4,1]
C0036337
UMLS CUI [4,2]
C4071830
UMLS CUI [5,1]
C0036358
UMLS CUI [5,2]
C4071830
UMLS CUI [6,1]
C0011251
UMLS CUI [6,2]
C4071830
UMLS CUI [7]
C0871189
5. abuse of or dependence on alcohol or other substances within the past 3 months as determined by scid, and score of > 8 on audit-c and confirmed by study physician interview
Beskrivning

Substance Use Disorders AUDIT-C | Substance Dependence AUDIT-C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C3871151
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C3871151
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 | Psychiatric referral Urgent

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
UMLS CUI [5,1]
C0420390
UMLS CUI [5,2]
C0439609
7. contraindication to venlafaxine or buprenorphine as determined by pcp and study physician including history of intolerance of either venlafaxine or buprenorphine in the study target dosage range (venlafaxine at up to 300 mg/day; buprenorphine at up to 1.2 mg/day)
Beskrivning

Medical contraindication Venlafaxine | Medical contraindication Buprenorphine | Intolerance to Venlafaxine U/day | Intolerance to Buprenorphine U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0078569
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0006405
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0078569
UMLS CUI [3,3]
C0456683
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0006405
UMLS CUI [4,3]
C0456683
8. 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
9. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
Beskrivning

Hypesthesia | Correction Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1]
C0020580
UMLS CUI [2,1]
C1947976
UMLS CUI [2,2]
C1272705
10. 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 and study physician's clinical judgment. referral to the patient's personal physician or to a general practitioner will be made in these cases
Beskrivning

Illness Unstable | Delirium | Diabetic - poor control | Hypertensive disease | Hyperlipidemia | Risk factors Cerebrovascular | Risk factor for cardiovascular disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
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]
C0847284
11. subjects taking psychotropic medications that cannot be safely tapered and discontinued prior to study initiation. the following exceptions are allowed if they have been taken at a stable dose for at least 4 weeks prior to study entry and there is not a plan to change the dose during the next 32 -36 weeks: benzodiazepines up to 2 mg/d lorazepam equivalent; other sedative-hypnotics (e.g., zolpidem, zaleplon, eszopiclone); gabapentin if prescribed for non-psychiatric indication (e.g., neuropathy)
Beskrivning

Psychotropic Drugs | Exception Benzodiazepines Dose Stable | Exception Lorazepam Dose | Exception Hypnotics and Sedatives Dose Stable | Exception Zolpidem | Exception Zaleplon | Exception Eszopiclone | Exception Gabapentin Neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005064
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024002
UMLS CUI [3,3]
C0178602
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0020592
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0205360
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0078839
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0251504
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1436328
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0060926
UMLS CUI [8,3]
C0442874
12. history of opiate abuse or dependence
Beskrivning

Opiate Abuse | Opiate Addiction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376196
UMLS CUI [1,2]
C1546935
UMLS CUI [2]
C0524662
13. severe pain, defined as > 7 on 0-10 numeric rating scale for pain
Beskrivning

Severe pain Numeric Rating Scale for Pain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0278140
UMLS CUI [1,2]
C1518471
14. concomitant use of strong or moderate cyp3a4 inhibitor (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketonazole, nefazodone, saquinovir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem)
Beskrivning

CYP3A4 Inhibitor Strong | CYP3A4 Inhibitor Moderate | Indinavir | Nelfinavir | Ritonavir | Clarithromycin | Itraconazole | Ketoconazole | nefazodone | Saquinavir | telithromycin | aprepitant | Erythromycin | Fluconazole | GRAPEFRUIT JUICE | Verapamil | Diltiazem

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3830624
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3830624
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C0376637
UMLS CUI [4]
C0525005
UMLS CUI [5]
C0292818
UMLS CUI [6]
C0055856
UMLS CUI [7]
C0064113
UMLS CUI [8]
C0022625
UMLS CUI [9]
C0068485
UMLS CUI [10]
C0286738
UMLS CUI [11]
C0907410
UMLS CUI [12]
C1176306
UMLS CUI [13]
C0014806
UMLS CUI [14]
C0016277
UMLS CUI [15]
C0452456
UMLS CUI [16]
C0042523
UMLS CUI [17]
C0012373
15. refusal to stop all opioids (to avoid precipitating opioid withdrawal)
Beskrivning

Opioids Discontinue Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242402
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1705116
16. refusal to discontinue all alcohol (to reduce the risk of respiratory depression)
Beskrivning

Alcohol consumption Discontinue Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1705116
17. hepatic impairment (ast/alt > 1.5 times upper normal)
Beskrivning

Hepatic impairment | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
18. estimated glomerular filtration rate (gfr) < 20 ml/min
Beskrivning

Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C3811844
19. inability/refusal to identify a person as an emergency contact
Beskrivning

Emergency contact Identification Unable | Emergency contact Identification Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1552023
UMLS CUI [1,2]
C0205396
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1552023
UMLS CUI [2,2]
C0205396
UMLS CUI [2,3]
C1705116
Tillbaka till toppen

Similar models

Eligibility Major Depressive Disorder NCT02263248

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age > 50 years
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder | Major Depressive Disorder Recurrent
Item
2. major depressive disorder (mdd), single or recurrent, as diagnosed by the scid-iv (or scid-5 if available)
boolean
C1269683 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
3. madrs > 15
boolean
C4054475 (UMLS CUI [1])
Relationship Clinical Primary Care Physician
Item
4. has or agrees to establish a clinical relationship with primary care physician (pcp).
boolean
C0439849 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0033131 (UMLS CUI [1,3])
Availability of Informant | Availability of Emergency contact
Item
5. availability of an informant (e.g., emergency contact) is encouraged but not required for study participation
boolean
C0470187 (UMLS CUI [1,1])
C1550484 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C1552023 (UMLS CUI [2,2])
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 Negligible MADRS
Item
2. depressive symptoms not severe enough (i.e., madrs < 15) at the baseline assessments
boolean
C0086132 (UMLS CUI [1,1])
C0332269 (UMLS CUI [1,2])
C4054475 (UMLS CUI [1,3])
Dementia
Item
3. dementia, as defined by 3ms < 80 and clinical evidence of dementia
boolean
C0497327 (UMLS CUI [1])
Bipolar I disorder Lifetime | Bipolar II disorder Lifetime | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime | Schizophreniform Disorders Lifetime | Delusional disorder Lifetime | 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
boolean
C0853193 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0236788 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C0036341 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
C0036337 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0036358 (UMLS CUI [5,1])
C4071830 (UMLS CUI [5,2])
C0011251 (UMLS CUI [6,1])
C4071830 (UMLS CUI [6,2])
C0871189 (UMLS CUI [7])
Substance Use Disorders AUDIT-C | Substance Dependence AUDIT-C
Item
5. abuse of or dependence on alcohol or other substances within the past 3 months as determined by scid, and score of > 8 on audit-c and confirmed by study physician interview
boolean
C0038586 (UMLS CUI [1,1])
C3871151 (UMLS CUI [1,2])
C0038580 (UMLS CUI [2,1])
C3871151 (UMLS CUI [2,2])
High suicide risk | Suicidal intent | Planning suicide | Hospitalization Unwilling | Psychiatric referral Urgent
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])
C0420390 (UMLS CUI [5,1])
C0439609 (UMLS CUI [5,2])
Medical contraindication Venlafaxine | Medical contraindication Buprenorphine | Intolerance to Venlafaxine U/day | Intolerance to Buprenorphine U/day
Item
7. contraindication to venlafaxine or buprenorphine as determined by pcp and study physician including history of intolerance of either venlafaxine or buprenorphine in the study target dosage range (venlafaxine at up to 300 mg/day; buprenorphine at up to 1.2 mg/day)
boolean
C1301624 (UMLS CUI [1,1])
C0078569 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0006405 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0078569 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0006405 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
Lacking Able to communicate English Language
Item
8. 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 | Correction Unsuccessful
Item
9. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
boolean
C0020580 (UMLS CUI [1])
C1947976 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Illness Unstable | Delirium | Diabetic - poor control | Hypertensive disease | Hyperlipidemia | Risk factors Cerebrovascular | Risk factor for cardiovascular disease
Item
10. 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 and study physician's clinical judgment. referral to the patient's personal physician or to a general practitioner will be made in these cases
boolean
C0221423 (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])
C0847284 (UMLS CUI [7])
Psychotropic Drugs | Exception Benzodiazepines Dose Stable | Exception Lorazepam Dose | Exception Hypnotics and Sedatives Dose Stable | Exception Zolpidem | Exception Zaleplon | Exception Eszopiclone | Exception Gabapentin Neuropathy
Item
11. subjects taking psychotropic medications that cannot be safely tapered and discontinued prior to study initiation. the following exceptions are allowed if they have been taken at a stable dose for at least 4 weeks prior to study entry and there is not a plan to change the dose during the next 32 -36 weeks: benzodiazepines up to 2 mg/d lorazepam equivalent; other sedative-hypnotics (e.g., zolpidem, zaleplon, eszopiclone); gabapentin if prescribed for non-psychiatric indication (e.g., neuropathy)
boolean
C0033978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005064 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0024002 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0020592 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205360 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0078839 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0251504 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C1436328 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0060926 (UMLS CUI [8,2])
C0442874 (UMLS CUI [8,3])
Opiate Abuse | Opiate Addiction
Item
12. history of opiate abuse or dependence
boolean
C0376196 (UMLS CUI [1,1])
C1546935 (UMLS CUI [1,2])
C0524662 (UMLS CUI [2])
Severe pain Numeric Rating Scale for Pain
Item
13. severe pain, defined as > 7 on 0-10 numeric rating scale for pain
boolean
C0278140 (UMLS CUI [1,1])
C1518471 (UMLS CUI [1,2])
CYP3A4 Inhibitor Strong | CYP3A4 Inhibitor Moderate | Indinavir | Nelfinavir | Ritonavir | Clarithromycin | Itraconazole | Ketoconazole | nefazodone | Saquinavir | telithromycin | aprepitant | Erythromycin | Fluconazole | GRAPEFRUIT JUICE | Verapamil | Diltiazem
Item
14. concomitant use of strong or moderate cyp3a4 inhibitor (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketonazole, nefazodone, saquinovir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem)
boolean
C3830624 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3830624 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0376637 (UMLS CUI [3])
C0525005 (UMLS CUI [4])
C0292818 (UMLS CUI [5])
C0055856 (UMLS CUI [6])
C0064113 (UMLS CUI [7])
C0022625 (UMLS CUI [8])
C0068485 (UMLS CUI [9])
C0286738 (UMLS CUI [10])
C0907410 (UMLS CUI [11])
C1176306 (UMLS CUI [12])
C0014806 (UMLS CUI [13])
C0016277 (UMLS CUI [14])
C0452456 (UMLS CUI [15])
C0042523 (UMLS CUI [16])
C0012373 (UMLS CUI [17])
Opioids Discontinue Refused
Item
15. refusal to stop all opioids (to avoid precipitating opioid withdrawal)
boolean
C0242402 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
Alcohol consumption Discontinue Refused
Item
16. refusal to discontinue all alcohol (to reduce the risk of respiratory depression)
boolean
C0001948 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
Hepatic impairment | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
17. hepatic impairment (ast/alt > 1.5 times upper normal)
boolean
C0948807 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Estimated Glomerular Filtration Rate
Item
18. estimated glomerular filtration rate (gfr) < 20 ml/min
boolean
C3811844 (UMLS CUI [1])
Emergency contact Identification Unable | Emergency contact Identification Refused
Item
19. inability/refusal to identify a person as an emergency contact
boolean
C1552023 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1552023 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C1705116 (UMLS CUI [2,3])
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