ID

15436

Beschrijving

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

Trefwoorden

Versies (1)
  1. 31-05-16 31-05-16 -
Geüploaded op

31 mei 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02332954

Engels

Eligibility Major Depressive Disorder NCT02332954

1 Formulieren  
Inclusion Criteria
Beschrijving

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)
Beschrijving

Age | British Columbia | Informed Consent

Datatype

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.
Beschrijving

Do volunteer work | Patient occupation | Vocational training

Datatype

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.
Beschrijving

Outpatient Consultation Primary Care Physicians | Outpatient Consultation Psychiatrist

Datatype

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.
Beschrijving

Major Depressive Disorder DSM-V

Datatype

boolean

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

Single major depressive episode

Datatype

boolean

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

Single major depressive episode Duration

Datatype

boolean

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

Depressive Symptoms Score

Datatype

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.
Beschrijving

symptoms; cognitive functions | Level Minimal

Datatype

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).
Beschrijving

Able to communicate Research Personnel | Digit Symbol Substitution Test Ability

Datatype

boolean

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

Exclusion Criteria

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

DSST Score

Datatype

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.
Beschrijving

Study Protocol | DSST | Compliance behavior Limited

Datatype

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.
Beschrijving

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

Datatype

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).
Beschrijving

Depressive Symptoms Resistant to Antidepressant therapy

Datatype

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.
Beschrijving

Inclusion criteria Other | Exclusion Criteria Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0205394
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Similar models

Eligibility Major Depressive Disorder NCT02332954

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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