ID

39358

Description

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

Lien

https://clinicaltrials.gov/show/NCT01685931

Mots-clés

Versions (2)
  1. 19/01/2019 19/01/2019 -
  2. 31/12/2019 31/12/2019 -
Détendeur de droits

see on clinicaltrials.gov

Téléchargé le

31 décembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01685931

Anglais

Eligibility Schizophrenia NCT01685931

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
previous diagnosis of schizophrenia
Description

diagnosis of schizophrenia

Type de données

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
Description

acute episode

Type de données

boolean

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

current antipsychotic treatment

Type de données

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
Description

medically stable in clinical laboratory tests

Type de données

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
a primary diagnosis other than schizophrenia
Description

primary diagnosis other than schizophrenia

Type de données

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
Description

history of risperidone or paliperidone resistance

Type de données

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
Description

clozapine for refractory schizophrenia

Type de données

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
Description

limit to participation according to the investigator

Type de données

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
Description

pregnancy, breastfeeding or planned pregnancy

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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