ID

15436

Description

Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine; ODM derived from: https://clinicaltrials.gov/show/NCT02332954

Link

https://clinicaltrials.gov/show/NCT02332954

Keywords

Versions (1)
  1. 5/31/16 5/31/16 -
Uploaded on

May 31, 2016

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 NCT02332954

English

Eligibility Major Depressive Disorder NCT02332954

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient is a man or woman, aged ≥18 years and <65 years (in the province of british columbia, the patient must be aged 19 years or older in order to give informed consent)
Description

Age | British Columbia | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0006193
UMLS CUI [3]
C0021430
the patient is engaged in volunteer work or gainful employment (working ≥20 hours per week) or is enrolled full-time in post-secondary studies or vocational training.
Description

Do volunteer work | Patient occupation | Vocational training

Data type

boolean

Alias
UMLS CUI [1]
C3842670
UMLS CUI [2]
C0421456
UMLS CUI [3]
C0204116
the patient is an outpatient consulting a primary care physician or a psychiatrist.
Description

Outpatient Consultation Primary Care Physicians | Outpatient Consultation Psychiatrist

Data type

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0009818
UMLS CUI [1,3]
C0033131
UMLS CUI [2,1]
C0029921
UMLS CUI [2,2]
C0009818
UMLS CUI [2,3]
C0033872
patients must have a diagnosis of mdd according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5™) classification code 296.3x.
Description

Major Depressive Disorder DSM-V

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C1137105
the current mde is confirmed by the investigator.
Description

Single major depressive episode

Data type

boolean

Alias
UMLS CUI [1]
C0024517
the reported duration of the current mde is at least 3 months.
Description

Single major depressive episode Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
the patient has a baseline score ≥15 on the qids-sr.
Description

Depressive Symptoms Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C0449820
the patient reports at least a minimal level of cognitive symptoms as defined by baseline score of ≥30 on the pdq-d-20.
Description

symptoms; cognitive functions | Level Minimal

Data type

boolean

Alias
UMLS CUI [1]
C1392787
UMLS CUI [2,1]
C0441889
UMLS CUI [2,2]
C0547040
the patient is capable of communicating with the site personnel and is able to conduct the digit-symbol substitution test (dsst).
Description

Able to communicate Research Personnel | Digit Symbol Substitution Test Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C0814254
UMLS CUI [2,2]
C0085732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient score is >69 on the dsst at screening/baseline.
Description

DSST Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0814254
UMLS CUI [1,2]
C0449820
the patient is, in the opinion of the investigator, not able to complete all the study assessments including, but not limited to, patient-reported assessments and the dsst.
Description

Study Protocol | DSST | Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1]
C2348563
UMLS CUI [2]
C0814254
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
the patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features.
Description

Manic episode | Hypomanic; episode | Schizophrenia | Psychotic Disorders | Major Depressive Disorder psychotic feature

Data type

boolean

Alias
UMLS CUI [1]
C0349208
UMLS CUI [2]
C1396834
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0033975
UMLS CUI [5,1]
C1269683
UMLS CUI [5,2]
C0743076
the current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each at the maximum recommended dose (according to canadian labeling).
Description

Depressive Symptoms Resistant to Antidepressant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C1096649
other protocol defined inclusion and exclusion criteria do apply.
Description

Inclusion criteria Other | Exclusion Criteria Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0205394
Back to the top of the page

Similar models

Eligibility Major Depressive Disorder NCT02332954

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | British Columbia | Informed Consent
Item
the patient is a man or woman, aged ≥18 years and <65 years (in the province of british columbia, the patient must be aged 19 years or older in order to give informed consent)
boolean
C0001779 (UMLS CUI [1])
C0006193 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Do volunteer work | Patient occupation | Vocational training
Item
the patient is engaged in volunteer work or gainful employment (working ≥20 hours per week) or is enrolled full-time in post-secondary studies or vocational training.
boolean
C3842670 (UMLS CUI [1])
C0421456 (UMLS CUI [2])
C0204116 (UMLS CUI [3])
Outpatient Consultation Primary Care Physicians | Outpatient Consultation Psychiatrist
Item
the patient is an outpatient consulting a primary care physician or a psychiatrist.
boolean
C0029921 (UMLS CUI [1,1])
C0009818 (UMLS CUI [1,2])
C0033131 (UMLS CUI [1,3])
C0029921 (UMLS CUI [2,1])
C0009818 (UMLS CUI [2,2])
C0033872 (UMLS CUI [2,3])
Major Depressive Disorder DSM-V
Item
patients must have a diagnosis of mdd according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5™) classification code 296.3x.
boolean
C1269683 (UMLS CUI [1,1])
C1137105 (UMLS CUI [1,2])
Single major depressive episode
Item
the current mde is confirmed by the investigator.
boolean
C0024517 (UMLS CUI [1])
Single major depressive episode Duration
Item
the reported duration of the current mde is at least 3 months.
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Depressive Symptoms Score
Item
the patient has a baseline score ≥15 on the qids-sr.
boolean
C0086132 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
symptoms; cognitive functions | Level Minimal
Item
the patient reports at least a minimal level of cognitive symptoms as defined by baseline score of ≥30 on the pdq-d-20.
boolean
C1392787 (UMLS CUI [1])
C0441889 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
Able to communicate Research Personnel | Digit Symbol Substitution Test Ability
Item
the patient is capable of communicating with the site personnel and is able to conduct the digit-symbol substitution test (dsst).
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0814254 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
DSST Score
Item
the patient score is >69 on the dsst at screening/baseline.
boolean
C0814254 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Study Protocol | DSST | Compliance behavior Limited
Item
the patient is, in the opinion of the investigator, not able to complete all the study assessments including, but not limited to, patient-reported assessments and the dsst.
boolean
C2348563 (UMLS CUI [1])
C0814254 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
Manic episode | Hypomanic; episode | Schizophrenia | Psychotic Disorders | Major Depressive Disorder psychotic feature
Item
the patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features.
boolean
C0349208 (UMLS CUI [1])
C1396834 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
C1269683 (UMLS CUI [5,1])
C0743076 (UMLS CUI [5,2])
Depressive Symptoms Resistant to Antidepressant therapy
Item
the current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each at the maximum recommended dose (according to canadian labeling).
boolean
C0086132 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C1096649 (UMLS CUI [1,3])
Inclusion criteria Other | Exclusion Criteria Other
Item
other protocol defined inclusion and exclusion criteria do apply.
boolean
C1512693 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
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