ID

22297

Description

A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00536471

Link

https://clinicaltrials.gov/show/NCT00536471

Keywords

  1. 5/29/17 5/29/17 -
Uploaded on

May 29, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT00536471

Eligibility Major Depressive Disorder NCT00536471

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatients
Description

Gender, outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0029921
aged 18-65 who meet the diagnostic and statistical manual of mental disorders fourth edition, text revision (dsm-iv-tr) diagnostic criteria for major depressive disorder (mdd)
Description

age, diagnostic criteria for major depressive disorder

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C2199206
have a montgomery-asberg depression rating scale (madrs) total score of at least 22 at visits 1 and 2
Description

montgomery-asberg depression rating scale

Data type

boolean

Alias
UMLS CUI [1]
C4054475
have a clinical global impressions of severity scale (cgi-s) score of at least 4 at visits 1 and 2
Description

clinical global impressions of severity scale

Data type

boolean

Alias
UMLS CUI [1,1]
C3639708
UMLS CUI [1,2]
C3639887
have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.
Description

informed consent, comprehension

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0162340
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients judged clinically to be at serious suicidal risk in the opinion of the investigator
Description

serious suicidal risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
patients who have any prior history of bipolar disorder, psychosis, or schizophrenia
Description

medical history bipolar disorder, psychosis or schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0005586
UMLS CUI [1,3]
C0033975
UMLS CUI [1,4]
C0036341
patients who have any current (within the past six months) dsm-iv-tr primary axis i disorder other than mdd
Description

dsm-iv-tr primary axis i disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0220952
UMLS CUI [1,3]
C0270287
patients with uncontrolled narrow-angle glaucoma
Description

uncontrolled narrow-angle glaucoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0154947
UMLS CUI [1,2]
C0205318
patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of the study.
Description

serious comorbidity, needs treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0205404
UMLS CUI [1,2]
C0009488
UMLS CUI [1,3]
C0815189

Similar models

Eligibility Major Depressive Disorder NCT00536471

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender, outpatients
Item
male or female outpatients
boolean
C0079399 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
age, diagnostic criteria for major depressive disorder
Item
aged 18-65 who meet the diagnostic and statistical manual of mental disorders fourth edition, text revision (dsm-iv-tr) diagnostic criteria for major depressive disorder (mdd)
boolean
C0001779 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C2199206 (UMLS CUI [2,2])
montgomery-asberg depression rating scale
Item
have a montgomery-asberg depression rating scale (madrs) total score of at least 22 at visits 1 and 2
boolean
C4054475 (UMLS CUI [1])
clinical global impressions of severity scale
Item
have a clinical global impressions of severity scale (cgi-s) score of at least 4 at visits 1 and 2
boolean
C3639708 (UMLS CUI [1,1])
C3639887 (UMLS CUI [1,2])
informed consent, comprehension
Item
have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
serious suicidal risk
Item
patients judged clinically to be at serious suicidal risk in the opinion of the investigator
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
medical history bipolar disorder, psychosis or schizophrenia
Item
patients who have any prior history of bipolar disorder, psychosis, or schizophrenia
boolean
C0262926 (UMLS CUI [1,1])
C0005586 (UMLS CUI [1,2])
C0033975 (UMLS CUI [1,3])
C0036341 (UMLS CUI [1,4])
dsm-iv-tr primary axis i disorder
Item
patients who have any current (within the past six months) dsm-iv-tr primary axis i disorder other than mdd
boolean
C0521116 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C0270287 (UMLS CUI [1,3])
uncontrolled narrow-angle glaucoma
Item
patients with uncontrolled narrow-angle glaucoma
boolean
C0154947 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
serious comorbidity, needs treatment
Item
patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of the study.
boolean
C0205404 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0815189 (UMLS CUI [1,3])

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