Information:
Fel:
ID
24581
Beskrivning
Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00467402
Länk
https://clinicaltrials.gov/show/NCT00467402
Nyckelord
Versioner (1)
- 2017-08-07 2017-08-07 -
Uppladdad den
7 augusti 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00467402
Eligibility Major Depressive Disorder NCT00467402
- StudyEvent: Eligibility
Similar models
Eligibility Major Depressive Disorder NCT00467402
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Adult | Age
Item
male and female adults, 18 through 70 years of age, inclusive
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Major Depressive Disorder Recurrent episode
Item
diagnosis of major depressive disorder, recurrent episode, according to diagnostic and statistical manual of mental disorders - 4th edition (dsm-iv) criteria
boolean
C1269683 (UMLS CUI [1,1])
C0443287 (UMLS CUI [1,2])
C0443287 (UMLS CUI [1,2])
Single major depressive episode Quantity
Item
a history of at least two previous episodes of major depression plus the current episode
boolean
C0024517 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Hamilton rating scale for depression
Item
hamilton depression rating scale (ham-d17) total score ≥ 22 at screening and baseline
boolean
C0451203 (UMLS CUI [1])
Bipolar I disorder | Bipolar II disorder | Schizophrenia | Schizoaffective Disorder | Eating Disorders | Obsessive-Compulsive Disorder
Item
history of bipolar disorder (i or ii), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
boolean
C0853193 (UMLS CUI [1])
C0236788 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0013473 (UMLS CUI [5])
C0028768 (UMLS CUI [6])
C0236788 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0013473 (UMLS CUI [5])
C0028768 (UMLS CUI [6])
Axis I diagnosis | Exception Major Depressive Disorder
Item
any current axis i disorder other than major depressive disorder which is the focus of treatment
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
Substance Use Disorders | Substance Dependence
Item
substance or alcohol abuse in the last 30 days, dependence in the last 6 months
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0038580 (UMLS CUI [2])
Psychotropic Drugs
Item
use of any psychoactive medication after the screening visit
boolean
C0033978 (UMLS CUI [1])
Agomelatine
Item
patients who have been previously treated with agomelatine
boolean
C0971637 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Lacking
Item
female patients of childbearing potential who are not using effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])