ID

32319

Description

The Efficacy and Safety of Quetiapine XR in Patients With Schizophrenia Switched From Other Antipsychotics; ODM derived from: https://clinicaltrials.gov/show/NCT02142556

Link

https://clinicaltrials.gov/show/NCT02142556

Keywords

Versions (1)
  1. 10/26/18 10/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 26, 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.

Back to model comments
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 NCT02142556

English

Eligibility Schizophrenia NCT02142556

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the participants who were aged from 20 to 65 years and met the diagnosis of schizophrenia according to diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) were eligible for the recruitment to the clinical trial.
Description

Age | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0036341
they also fulfilled the criteria including having a score of 4 (moderate) or greater on any of the 7 items of the positive and negative syndrome scale (panss) positive symptom subscale and needed to switch from previous antipsychotics due to insufficient efficacy or insufficient tolerability.
Description

PANSS | Subscale score Symptoms Positive | Patient need for Change Antipsychotic Agents | Etiology Effectiveness Insufficient | Etiology Intolerance to substance

Data type

boolean

Alias
UMLS CUI [1]
C4086747
UMLS CUI [2,1]
C0459443
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0040615
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C1280519
UMLS CUI [4,3]
C0231180
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C1744706
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any dsm-iv-tr axis i disorder other than schizophrenia, except comorbid obsessive-compulsive disorder, anxiety disorder, eating disorders or impulse control disorders if they had been stable and had not been primary focus of treatment over the previous 6 months
Description

Axis I diagnosis | Exception Schizophrenia | Exception Obsessive-Compulsive Disorder Stable | Exception Anxiety Disorders Stable | Exception Eating Disorders Stable | Exception Impulse control disorder Stable

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028768
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0003469
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0013473
UMLS CUI [5,3]
C0205360
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0868740
UMLS CUI [6,3]
C0205360
an imminent risk of suicide or a danger to self or others
Description

At risk for suicide | DANGER OF HARM TO SELF | At risk of harming others

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C0149660
UMLS CUI [3]
C1271966
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
intolerance or lack of response to quetiapine ir
Description

Intolerance to Quetiapine IR | Quetiapine IR Response Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0123091
UMLS CUI [1,3]
C1708470
UMLS CUI [2,1]
C0123091
UMLS CUI [2,2]
C1708470
UMLS CUI [2,3]
C1704632
UMLS CUI [2,4]
C0332268
use of cytochrome p450 3a4 inhibitors or inducers in the 14 days preceding enrolment
Description

CYP3A4 Inhibitors | CYP3A4 Inducers

Data type

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C3850041
administration of a depot antipsychotic injection within one dosing interval before recruitment
Description

Injection of depot antipsychotic agent

Data type

boolean

Alias
UMLS CUI [1]
C2585377
unstable or inadequately treated medical illness as judged by the investigator.
Description

Illness Unstable | Illness Treated Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205412
Back to the top of the page

Similar models

Eligibility Schizophrenia NCT02142556

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Schizophrenia
Item
the participants who were aged from 20 to 65 years and met the diagnosis of schizophrenia according to diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) were eligible for the recruitment to the clinical trial.
boolean
C0001779 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
PANSS | Subscale score Symptoms Positive | Patient need for Change Antipsychotic Agents | Etiology Effectiveness Insufficient | Etiology Intolerance to substance
Item
they also fulfilled the criteria including having a score of 4 (moderate) or greater on any of the 7 items of the positive and negative syndrome scale (panss) positive symptom subscale and needed to switch from previous antipsychotics due to insufficient efficacy or insufficient tolerability.
boolean
C4086747 (UMLS CUI [1])
C0459443 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0040615 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C1280519 (UMLS CUI [4,2])
C0231180 (UMLS CUI [4,3])
C0015127 (UMLS CUI [5,1])
C1744706 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Exception Schizophrenia | Exception Obsessive-Compulsive Disorder Stable | Exception Anxiety Disorders Stable | Exception Eating Disorders Stable | Exception Impulse control disorder Stable
Item
any dsm-iv-tr axis i disorder other than schizophrenia, except comorbid obsessive-compulsive disorder, anxiety disorder, eating disorders or impulse control disorders if they had been stable and had not been primary focus of treatment over the previous 6 months
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0028768 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0003469 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0013473 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0868740 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
At risk for suicide | DANGER OF HARM TO SELF | At risk of harming others
Item
an imminent risk of suicide or a danger to self or others
boolean
C0563664 (UMLS CUI [1])
C0149660 (UMLS CUI [2])
C1271966 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Intolerance to Quetiapine IR | Quetiapine IR Response Lacking
Item
intolerance or lack of response to quetiapine ir
boolean
C1744706 (UMLS CUI [1,1])
C0123091 (UMLS CUI [1,2])
C1708470 (UMLS CUI [1,3])
C0123091 (UMLS CUI [2,1])
C1708470 (UMLS CUI [2,2])
C1704632 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
CYP3A4 Inhibitors | CYP3A4 Inducers
Item
use of cytochrome p450 3a4 inhibitors or inducers in the 14 days preceding enrolment
boolean
C3850053 (UMLS CUI [1])
C3850041 (UMLS CUI [2])
Injection of depot antipsychotic agent
Item
administration of a depot antipsychotic injection within one dosing interval before recruitment
boolean
C2585377 (UMLS CUI [1])
Illness Unstable | Illness Treated Inadequate
Item
unstable or inadequately treated medical illness as judged by the investigator.
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial