Information:
Error:
ID
32043
Description
Quetiapine Extended Release Depression Symptoms; ODM derived from: https://clinicaltrials.gov/show/NCT00640562
Link
https://clinicaltrials.gov/show/NCT00640562
Keywords
Versions (1)
- 10/15/18 10/15/18 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
October 15, 2018
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 Schizophrenia NCT00640562
Eligibility Schizophrenia NCT00640562
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT00640562
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Informed Consent
Item
provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
Schizophrenia | Schizoaffective Disorder
Item
patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to dsm-ivtr
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0036337 (UMLS CUI [2])
Depressive Symptoms Hamilton Depression Rating Scale 21-Item Clinical Classification | Depressive Symptoms Hamilton rating scale for depression
Item
baseline depressive symptoms, assessed by means of ham-d (21-item) score ≥20, and ham-d item 1 score ≥2
boolean
C0086132 (UMLS CUI [1,1])
C3640518 (UMLS CUI [1,2])
C0086132 (UMLS CUI [2,1])
C0451203 (UMLS CUI [2,2])
C3640518 (UMLS CUI [1,2])
C0086132 (UMLS CUI [2,1])
C0451203 (UMLS CUI [2,2])
Axis I diagnosis | Exception Schizophrenia | Exception Schizoaffective Disorder
Item
any dsm-iv axis i disorder other than schizophrenia and schizoaffective disorder
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0036337 (UMLS CUI [3,2])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0036337 (UMLS CUI [3,2])
Injection of depot antipsychotic agent | Antipsychotic Agents Oral | Exception Drug Switching
Item
patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other ap oral medications during the trial except for the switch period
boolean
C2585377 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2936279 (UMLS CUI [3,2])
C0040615 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2936279 (UMLS CUI [3,2])
Clozapine | Clozapine non-responder
Item
use of clozapine within 28 days prior to enrollment or clozapine non responders
boolean
C0009079 (UMLS CUI [1])
C0009079 (UMLS CUI [2,1])
C0919875 (UMLS CUI [2,2])
C0009079 (UMLS CUI [2,1])
C0919875 (UMLS CUI [2,2])
Disease Clinical Significance | Patient Inappropriate Investigational New Drugs
Item
any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C2826293 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Absolute neutrophil count
Item
an absolute neutrophil count (anc) of ≤1.5 x 109 per liter
boolean
C0948762 (UMLS CUI [1])
At risk for suicide | At risk for deliberate self harm | At risk of harming others
Item
patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
boolean
C0563664 (UMLS CUI [1])
C1276053 (UMLS CUI [2])
C1271966 (UMLS CUI [3])
C1276053 (UMLS CUI [2])
C1271966 (UMLS CUI [3])
No comments