ID

22906

Description

Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001); ODM derived from: https://clinicaltrials.gov/show/NCT00610649

Lien

https://clinicaltrials.gov/show/NCT00610649

Mots-clés

  1. 16/06/2017 16/06/2017 -
Téléchargé le

16 juin 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Depression NCT00610649

Eligibility Depression NCT00610649

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00610649
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female who is non-pregnant, nonlactating, using an acceptable method of birth control, or is not of child-bearing potential;
Description

ID.1

Type de données

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0032961
be diagnosed with current major depressive disorder either mild or severe, as evidenced by a score of at least 9 but not more than 20 on the quick inventory of depression symptomatology - clinician rated (qids-c);
Description

ID.2

Type de données

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C4300148
be anti-depressant naïve;
Description

ID.3

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0919936
be able to refrain from all use of grapefruit containing products from the time of admission until the last assessment is performed at discharge;
Description

ID.4

Type de données

boolean

smokes less than or equal to 10 cigarettes or equivalent daily.
Description

ID.5

Type de données

boolean

Alias
UMLS CUI [1]
C0453996
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has any current and primary axis i disorder other than major depressive disorder;
Description

ID.6

Type de données

boolean

Alias
UMLS CUI [1]
C0270287
has any history of bipolar i or ii disorder, dysthymia, psychotic depression, psychotic disorders, posttraumatic stress disorder, borderline personality disorder, obsessive compulsive disorder, or eating disorder;
Description

ID.7

Type de données

boolean

Alias
UMLS CUI [1]
C0004936
the duration of the current depressive episode is longer than 2 years at screening;
Description

ID.8

Type de données

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0580798
has any history of a significant suicide attempt, or poses a current risk of attempting suicide;
Description

ID.9

Type de données

boolean

Alias
UMLS CUI [1,1]
C0438696
UMLS CUI [1,2]
C0455507
is known to be human immunodeficiency virus (hiv) positive, or positive for hepatitis b surface antigen or hepatitis a antibodies or hepatitis c total antibodies;
Description

ID.10

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0019196
UMLS CUI [1,4]
C0019159
has any clinically significant concurrent endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, malignancy, or any other concurrent medical condition, or has any history of diabetes mellitus;
Description

ID.11

Type de données

boolean

Alias
UMLS CUI [1]
C0012634
donation of blood within 60 days prior to the anticipated first dose of trial medication.
Description

ID.12

Type de données

boolean

Alias
UMLS CUI [1]
C0005794

Similar models

Eligibility Depression NCT00610649

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00610649
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
female who is non-pregnant, nonlactating, using an acceptable method of birth control, or is not of child-bearing potential;
boolean
C0043210 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
ID.2
Item
be diagnosed with current major depressive disorder either mild or severe, as evidenced by a score of at least 9 but not more than 20 on the quick inventory of depression symptomatology - clinician rated (qids-c);
boolean
C1269683 (UMLS CUI [1,1])
C4300148 (UMLS CUI [1,2])
ID.3
Item
be anti-depressant naïve;
boolean
C0003289 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
ID.4
Item
be able to refrain from all use of grapefruit containing products from the time of admission until the last assessment is performed at discharge;
boolean
ID.5
Item
smokes less than or equal to 10 cigarettes or equivalent daily.
boolean
C0453996 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
has any current and primary axis i disorder other than major depressive disorder;
boolean
C0270287 (UMLS CUI [1])
ID.7
Item
has any history of bipolar i or ii disorder, dysthymia, psychotic depression, psychotic disorders, posttraumatic stress disorder, borderline personality disorder, obsessive compulsive disorder, or eating disorder;
boolean
C0004936 (UMLS CUI [1])
ID.8
Item
the duration of the current depressive episode is longer than 2 years at screening;
boolean
C1269683 (UMLS CUI [1,1])
C0580798 (UMLS CUI [1,2])
ID.9
Item
has any history of a significant suicide attempt, or poses a current risk of attempting suicide;
boolean
C0438696 (UMLS CUI [1,1])
C0455507 (UMLS CUI [1,2])
ID.10
Item
is known to be human immunodeficiency virus (hiv) positive, or positive for hepatitis b surface antigen or hepatitis a antibodies or hepatitis c total antibodies;
boolean
C0019682 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0019159 (UMLS CUI [1,4])
ID.11
Item
has any clinically significant concurrent endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, malignancy, or any other concurrent medical condition, or has any history of diabetes mellitus;
boolean
C0012634 (UMLS CUI [1])
ID.12
Item
donation of blood within 60 days prior to the anticipated first dose of trial medication.
boolean
C0005794 (UMLS CUI [1])

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