ID

41605

Beschrijving

Brexpiprazole in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01810783 according to the information on www.clinicaltrials.gov other inclusion and exclusion criteria may apply.

Link

https://clinicaltrials.gov/show/NCT01810783

Trefwoorden

Versies (1)
  1. 24-11-20 24-11-20 -
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see on clinicaltrials.gov

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24 november 2020

DOI

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Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01810783

Engels

Eligibility Schizophrenia NCT01810783

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient has completed the lead-in study 14644a.
Beschrijving

study subject participation status completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205197
the patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.
Beschrijving

potential benefit from treatment with brexpiprazol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332149
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C3885614
the patient agrees to protocol-defined use of effective contraception.
Beschrijving

protocol-defined use of contraception

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during study 14644a.
Beschrijving

primary psychiatric disorder other than schizophrenia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205225
UMLS CUI [1,2]
C0004936
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0036341
the patient has a clinically significant unstable illness diagnosed during study 14644a.
Beschrijving

clinically significant unstable disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0443343
the patient, in the opinion of the investigator or according to columbia-suicide severity rating scale (c-ssrs), is at significant risk of suicide.
Beschrijving

judgement of investigator or according to columbia-suicide severity rating scale (c-ssrs): significant risk of suicide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022423
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0750502
UMLS CUI [1,4]
C0563664
UMLS CUI [2,1]
C3888485
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0563664
the patient has an abnormal ecg or other abnormal ecg tests that are, in the investigator's opinion, clinically significant.
Beschrijving

investigator's judgement: clinically significant abnormal ecg

Datatype

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0022423
UMLS CUI [1,4]
C0008961
the patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Beschrijving

investigator's judgment: unlikely to comply with the protocol or is unsuitable for any reason

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022423
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0525058
UMLS CUI [1,4]
C0750558
UMLS CUI [2,1]
C0022423
UMLS CUI [2,2]
C0008961
UMLS CUI [2,3]
C3844399
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Similar models

Eligibility Schizophrenia NCT01810783

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
study subject participation status completed
Item
the patient has completed the lead-in study 14644a.
boolean
C2348568 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
potential benefit from treatment with brexpiprazol
Item
the patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.
boolean
C0332149 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C3885614 (UMLS CUI [1,3])
protocol-defined use of contraception
Item
the patient agrees to protocol-defined use of effective contraception.
boolean
C0700589 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
primary psychiatric disorder other than schizophrenia
Item
the patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during study 14644a.
boolean
C0205225 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
clinically significant unstable disease
Item
the patient has a clinically significant unstable illness diagnosed during study 14644a.
boolean
C2826293 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
judgement of investigator or according to columbia-suicide severity rating scale (c-ssrs): significant risk of suicide
Item
the patient, in the opinion of the investigator or according to columbia-suicide severity rating scale (c-ssrs), is at significant risk of suicide.
boolean
C0022423 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0563664 (UMLS CUI [1,4])
C3888485 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0563664 (UMLS CUI [2,3])
investigator's judgement: clinically significant abnormal ecg
Item
the patient has an abnormal ecg or other abnormal ecg tests that are, in the investigator's opinion, clinically significant.
boolean
C0522055 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,4])
investigator's judgment: unlikely to comply with the protocol or is unsuitable for any reason
Item
the patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
boolean
C0022423 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0750558 (UMLS CUI [1,4])
C0022423 (UMLS CUI [2,1])
C0008961 (UMLS CUI [2,2])
C3844399 (UMLS CUI [2,3])
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