Information:
Error:
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
Link
https://clinicaltrials.gov/show/NCT00610649
Keywords
Versions (1)
- 6/16/17 6/16/17 -
Uploaded on
June 16, 2017
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Depression NCT00610649
Eligibility Depression NCT00610649
- StudyEvent: Eligibility
Similar models
Eligibility Depression NCT00610649
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
C4300148 (UMLS CUI [1,2])
ID.3
Item
be anti-depressant naïve;
boolean
C0003289 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
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])
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])
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])
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])
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])