ID

23241

Descrizione

Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00531947

collegamento

https://clinicaltrials.gov/show/NCT00531947

Keywords

  1. 30/06/17 30/06/17 -
Caricato su

30 giugno 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT00531947

Eligibility Major Depressive Disorder NCT00531947

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
male / female outpatients 12 to 17 years of age diagnosed with major depressive disorder (mdd). (must have a children's depression rating scale-revised [cdrs-r] with a total score of at least 45 at screening.)
Descrizione

ID.1

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1269683
female patients must test negative on a pregnancy at visit 1.
Descrizione

ID.2

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
weight and height must be greater than the 10th percentile according to age and height,
Descrizione

ID.3

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0005890
assent and consent must be given.
Descrizione

ID.4

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a serious or unstable medical illness, psychological condition, clinically significant laboratory or ecg result, hypersensitivity to selegiline, or any other condition that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study.
Descrizione

ID.5

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0020517
have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator.
Descrizione

ID.6

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004936
have a risk of suicide
Descrizione

ID.7

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0563664
female patients who are either pregnant, nursing or have recently given birth.
Descrizione

ID.8

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
use of any protocol prohibited medications or substances.
Descrizione

ID.9

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0138547
UMLS CUI [1,2]
C0013227

Similar models

Eligibility Major Depressive Disorder NCT00531947

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male / female outpatients 12 to 17 years of age diagnosed with major depressive disorder (mdd). (must have a children's depression rating scale-revised [cdrs-r] with a total score of at least 45 at screening.)
boolean
C0001779 (UMLS CUI [1,1])
C1269683 (UMLS CUI [1,2])
ID.2
Item
female patients must test negative on a pregnancy at visit 1.
boolean
C0032961 (UMLS CUI [1])
ID.3
Item
weight and height must be greater than the 10th percentile according to age and height,
boolean
C0005910 (UMLS CUI [1,1])
C0005890 (UMLS CUI [1,2])
ID.4
Item
assent and consent must be given.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.5
Item
have a serious or unstable medical illness, psychological condition, clinically significant laboratory or ecg result, hypersensitivity to selegiline, or any other condition that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study.
boolean
C0012634 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
ID.6
Item
have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator.
boolean
C0004936 (UMLS CUI [1])
ID.7
Item
have a risk of suicide
boolean
C0563664 (UMLS CUI [1])
ID.8
Item
female patients who are either pregnant, nursing or have recently given birth.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.9
Item
use of any protocol prohibited medications or substances.
boolean
C0138547 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])

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