Informatie:
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ID
22297
Beschrijving
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
Trefwoorden
Versies (1)
- 29-05-17 29-05-17 -
Geüploaded op
29 mei 2017
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00536471
Eligibility Major Depressive Disorder NCT00536471
- StudyEvent: Eligibility
Similar models
Eligibility Major Depressive Disorder NCT00536471
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Gender, outpatients
Item
male or female outpatients
boolean
C0079399 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
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])
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])
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])
C0162340 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
C0009488 (UMLS CUI [1,2])
C0815189 (UMLS CUI [1,3])