Informações:
Falhas:
ID
23241
Descrição
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00531947
Link
https://clinicaltrials.gov/show/NCT00531947
Palavras-chave
Versões (1)
- 30/06/2017 30/06/2017 -
Transferido a
30 de junho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00531947
Eligibility Major Depressive Disorder NCT00531947
- StudyEvent: Eligibility
Similar models
Eligibility Major Depressive Disorder NCT00531947
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
C0005890 (UMLS CUI [1,2])
ID.4
Item
assent and consent must be given.
boolean
C0021430 (UMLS CUI [1])
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])
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])
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])
C0013227 (UMLS CUI [1,2])