ID

36345

Beschrijving

A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD); ODM derived from: https://clinicaltrials.gov/show/NCT02085135

Link

https://clinicaltrials.gov/show/NCT02085135

Trefwoorden

Versies (1)
  1. 05-05-19 05-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02085135

Engels

Eligibility Major Depressive Disorder NCT02085135

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index of 18-40 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
have a diagnosis of mdd
Beschrijving

Major Depressive Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
have a current major depressive episode (mde) lasting 8 weeks to 24 months
Beschrijving

Major depressive episode Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
have been treated with an adequate dose of an approved antidepressant during the current mde for at least 8 weeks
Beschrijving

Antidepressant therapy Dose Adequate

Datatype

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205411
have an inadequate response to current antidepressant treatment
Beschrijving

Antidepressant therapy | Response Inadequate

Datatype

boolean

Alias
UMLS CUI [1]
C1096649
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
agree to use an approved method of birth control for the duration of the study
Beschrijving

Contraceptive methods Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
additional criteria may apply
Beschrijving

Inclusion criteria Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently pregnant or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of or current infection with hepatitis b virus, hepatitis c virus or human immunodeficiency virus (hiv)
Beschrijving

Hepatitis B | Hepatitis C | HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
have experienced hallucinations, delusions, or any psychotic symptoms in the current mde
Beschrijving

Hallucinations During Major depressive episode | Delusions During Major depressive episode | Psychotic symptom During Major depressive episode

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018524
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0024517
UMLS CUI [2,1]
C0011253
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0024517
UMLS CUI [3,1]
C0871189
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C0024517
have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
Beschrijving

Opioid Agonists | Codeine | Oxycodone | Tramadol | Morphine | Opioid Antagonists | Naloxone | Naltrexone

Datatype

boolean

Alias
UMLS CUI [1]
C1373059
UMLS CUI [2]
C0009214
UMLS CUI [3]
C0030049
UMLS CUI [4]
C0040610
UMLS CUI [5]
C0026549
UMLS CUI [6]
C2756979
UMLS CUI [7]
C0027358
UMLS CUI [8]
C0027360
have received electroconvulsive therapy treatment within the last 5 years
Beschrijving

Electroconvulsive Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0013806
have attempted suicide within the past 2 years
Beschrijving

Suicide attempt

Datatype

boolean

Alias
UMLS CUI [1]
C0038663
have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
Beschrijving

Intolerance to Buprenorphine | Buprenorphine allergy | Intolerance to Opioid Antagonists | Opioid antagonist allergy | Intolerance to Naltrexone | Naltrexone allergy | Intolerance to Naloxone | Naloxone allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0006405
UMLS CUI [2]
C0570524
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C2756979
UMLS CUI [4]
C0571190
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0027360
UMLS CUI [6]
C0571191
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0027358
UMLS CUI [8]
C0571192
have had a significant blood loss or blood donation with 60 days of screening
Beschrijving

Blood Loss Significant | Blood Donation

Datatype

boolean

Alias
UMLS CUI [1,1]
C3163616
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0005794
additional criteria may apply
Beschrijving

Exclusion Criteria Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Major Depressive Disorder NCT02085135

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
body mass index of 18-40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Major Depressive Disorder
Item
have a diagnosis of mdd
boolean
C1269683 (UMLS CUI [1])
Major depressive episode Duration
Item
have a current major depressive episode (mde) lasting 8 weeks to 24 months
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Antidepressant therapy Dose Adequate
Item
have been treated with an adequate dose of an approved antidepressant during the current mde for at least 8 weeks
boolean
C1096649 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
Antidepressant therapy | Response Inadequate
Item
have an inadequate response to current antidepressant treatment
boolean
C1096649 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Contraceptive methods Willing
Item
agree to use an approved method of birth control for the duration of the study
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Inclusion criteria Additional
Item
additional criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
currently pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B | Hepatitis C | HIV Infection
Item
history of or current infection with hepatitis b virus, hepatitis c virus or human immunodeficiency virus (hiv)
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Hallucinations During Major depressive episode | Delusions During Major depressive episode | Psychotic symptom During Major depressive episode
Item
have experienced hallucinations, delusions, or any psychotic symptoms in the current mde
boolean
C0018524 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0024517 (UMLS CUI [1,3])
C0011253 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0024517 (UMLS CUI [2,3])
C0871189 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C0024517 (UMLS CUI [3,3])
Opioid Agonists | Codeine | Oxycodone | Tramadol | Morphine | Opioid Antagonists | Naloxone | Naltrexone
Item
have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
boolean
C1373059 (UMLS CUI [1])
C0009214 (UMLS CUI [2])
C0030049 (UMLS CUI [3])
C0040610 (UMLS CUI [4])
C0026549 (UMLS CUI [5])
C2756979 (UMLS CUI [6])
C0027358 (UMLS CUI [7])
C0027360 (UMLS CUI [8])
Electroconvulsive Therapy
Item
have received electroconvulsive therapy treatment within the last 5 years
boolean
C0013806 (UMLS CUI [1])
Suicide attempt
Item
have attempted suicide within the past 2 years
boolean
C0038663 (UMLS CUI [1])
Intolerance to Buprenorphine | Buprenorphine allergy | Intolerance to Opioid Antagonists | Opioid antagonist allergy | Intolerance to Naltrexone | Naltrexone allergy | Intolerance to Naloxone | Naloxone allergy
Item
have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
boolean
C1744706 (UMLS CUI [1,1])
C0006405 (UMLS CUI [1,2])
C0570524 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C2756979 (UMLS CUI [3,2])
C0571190 (UMLS CUI [4])
C1744706 (UMLS CUI [5,1])
C0027360 (UMLS CUI [5,2])
C0571191 (UMLS CUI [6])
C1744706 (UMLS CUI [7,1])
C0027358 (UMLS CUI [7,2])
C0571192 (UMLS CUI [8])
Blood Loss Significant | Blood Donation
Item
have had a significant blood loss or blood donation with 60 days of screening
boolean
C3163616 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2])
Exclusion Criteria Additional
Item
additional criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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