Informatie:
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ID
21818
Beschrijving
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00411242
Link
https://clinicaltrials.gov/show/NCT00411242
Trefwoorden
Versies (2)
- 30-04-17 30-04-17 -
- 02-05-17 02-05-17 -
Geüploaded op
2 mei 2017
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Major Depressive Disorder (MDD) NCT00411242
Eligibility Major Depressive Disorder (MDD) NCT00411242
- StudyEvent: Eligibility
Similar models
Eligibility Major Depressive Disorder (MDD) NCT00411242
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Single major depressive episode | Recurrent major depressive episodes
Item
diagnosis of major depressive disorder, single or recurrent episode, according to dsm-iv criteria
boolean
C0024517 (UMLS CUI [1])
C0154409 (UMLS CUI [2])
C0154409 (UMLS CUI [2])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
ham-d17 total score > or = 22 at screening and baseline
boolean
C3639712 (UMLS CUI [1])
Clinical Global Impression Questionnaire
Item
cgi-severity score > or = 4 at screening and baseline
boolean
C3639708 (UMLS CUI [1])
Protocol Compliance Complete | Participation Open Label Study
Item
only patients who complete the core protocol are eligible to participate in the open-label extension phase
boolean
C0525058 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0679823 (UMLS CUI [2,1])
C1709323 (UMLS CUI [2,2])
C0205197 (UMLS CUI [1,2])
C0679823 (UMLS CUI [2,1])
C1709323 (UMLS CUI [2,2])
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 | 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])
C1269683 (UMLS CUI [2])
C1269683 (UMLS CUI [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 | Plant Preparations | Melatonin
Item
concomitant psychotropic medication, including herbal preparations and melatonin
boolean
C0033978 (UMLS CUI [1])
C0949854 (UMLS CUI [2])
C0025219 (UMLS CUI [3])
C0949854 (UMLS CUI [2])
C0025219 (UMLS CUI [3])
Psychotherapy
Item
psychotherapy of any type
boolean
C0033968 (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])