ID

39358

Descripción

A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics; ODM derived from: https://clinicaltrials.gov/show/NCT01685931

Link

https://clinicaltrials.gov/show/NCT01685931

Palabras clave

Versiones (2)
  1. 19/1/19 19/1/19 -
  2. 31/12/19 31/12/19 -
Titular de derechos de autor

see on clinicaltrials.gov

Subido en

31 de diciembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01685931

Inglés

Eligibility Schizophrenia NCT01685931

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
previous diagnosis of schizophrenia
Descripción

diagnosis of schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0262926
experiencing an acute episode, with a positive and negative syndrome scale (panss) total score between 70 and 120, inclusive
Descripción

acute episode

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0813173
UMLS CUI [1,2]
C4086747
patients currently treated with antipsychotic are allowed to be recruited
Descripción

current antipsychotic treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0040615
UMLS CUI [1,3]
C1302261
be medically stable on the basis of clinical laboratory tests performed at screening
Descripción

medically stable in clinical laboratory tests

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0220908
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
a primary diagnosis other than schizophrenia
Descripción

primary diagnosis other than schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4723751
UMLS CUI [1,2]
C0277554
UMLS CUI [1,3]
C0036341
history of risperidone or paliperidone resistance as defined by failure to respond to 2 adequate treatment periods
Descripción

history of risperidone or paliperidone resistance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0013203
UMLS CUI [1,3]
C0073393
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0013203
UMLS CUI [2,3]
C0753678
clozapine use for treatment refractory schizophrenia
Descripción

clozapine for refractory schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009079
UMLS CUI [1,2]
C2063865
relevant history or current presence of any significant or unstable condition, disease or illness that could limit the participation in the study according to the investigator
Descripción

limit to participation according to the investigator

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C2348568
UMLS CUI [1,5]
C0443288
UMLS CUI [1,6]
C0035173
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0521116
UMLS CUI [2,4]
C0443343
UMLS CUI [2,5]
C2348568
UMLS CUI [2,6]
C0443288
UMLS CUI [2,7]
C0035173
woman who is pregnant, breast-feeding, or is planning to become pregnant within 6 months
Descripción

pregnancy, breastfeeding or planned pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032992
UMLS CUI [3,2]
C0443303
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Similar models

Eligibility Schizophrenia NCT01685931

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
diagnosis of schizophrenia
Item
previous diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
acute episode
Item
experiencing an acute episode, with a positive and negative syndrome scale (panss) total score between 70 and 120, inclusive
boolean
C0813173 (UMLS CUI [1,1])
C4086747 (UMLS CUI [1,2])
current antipsychotic treatment
Item
patients currently treated with antipsychotic are allowed to be recruited
boolean
C0521116 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
C1302261 (UMLS CUI [1,3])
medically stable in clinical laboratory tests
Item
be medically stable on the basis of clinical laboratory tests performed at screening
boolean
C0205360 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
primary diagnosis other than schizophrenia
Item
a primary diagnosis other than schizophrenia
boolean
C4723751 (UMLS CUI [1,1])
C0277554 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
history of risperidone or paliperidone resistance
Item
history of risperidone or paliperidone resistance as defined by failure to respond to 2 adequate treatment periods
boolean
C0262926 (UMLS CUI [1,1])
C0013203 (UMLS CUI [1,2])
C0073393 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0013203 (UMLS CUI [2,2])
C0753678 (UMLS CUI [2,3])
clozapine for refractory schizophrenia
Item
clozapine use for treatment refractory schizophrenia
boolean
C0009079 (UMLS CUI [1,1])
C2063865 (UMLS CUI [1,2])
limit to participation according to the investigator
Item
relevant history or current presence of any significant or unstable condition, disease or illness that could limit the participation in the study according to the investigator
boolean
C0262926 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0443288 (UMLS CUI [1,5])
C0035173 (UMLS CUI [1,6])
C0262926 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
C0443343 (UMLS CUI [2,4])
C2348568 (UMLS CUI [2,5])
C0443288 (UMLS CUI [2,6])
C0035173 (UMLS CUI [2,7])
pregnancy, breastfeeding or planned pregnancy
Item
woman who is pregnant, breast-feeding, or is planning to become pregnant within 6 months
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3,1])
C0443303 (UMLS CUI [3,2])
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