ID

36345

Description

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

Keywords

Versions (1)
  1. 5/5/19 5/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 5, 2019

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 Major Depressive Disorder NCT02085135

English

Eligibility Major Depressive Disorder NCT02085135

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Body mass index

Data type

boolean

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

Major Depressive Disorder

Data type

boolean

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

Major depressive episode Duration

Data type

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
Description

Antidepressant therapy Dose Adequate

Data type

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
Description

Antidepressant therapy | Response Inadequate

Data type

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
Description

Contraceptive methods Willing

Data type

boolean

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

Inclusion criteria Additional

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

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)
Description

Hepatitis B | Hepatitis C | HIV Infection

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Electroconvulsive Therapy

Data type

boolean

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

Suicide attempt

Data type

boolean

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

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

Data type

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
Description

Blood Loss Significant | Blood Donation

Data type

boolean

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

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
Back to the top of the page

Similar models

Eligibility Major Depressive Disorder NCT02085135

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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