ID

32319

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02142556

Nyckelord

Versioner (1)
  1. 2018-10-26 2018-10-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02142556

Engelsk

Eligibility Schizophrenia NCT02142556

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

Age | Schizophrenia

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

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

Intolerance to Quetiapine IR | Quetiapine IR Response Lacking

Datatyp

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
Beskrivning

CYP3A4 Inhibitors | CYP3A4 Inducers

Datatyp

boolean

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

Injection of depot antipsychotic agent

Datatyp

boolean

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

Illness Unstable | Illness Treated Inadequate

Datatyp

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
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Similar models

Eligibility Schizophrenia NCT02142556

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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