ID

32135

Description

Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00827840

Lien

https://clinicaltrials.gov/show/NCT00827840

Mots-clés

Versions (1)
  1. 20/10/2018 20/10/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

20 octobre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00827840

Anglais

Eligibility Schizophrenia NCT00827840

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed as schizophrenia by dsm-iv-tr criteria both in inpatients
Description

Schizophrenia | Inpatient

Type de données

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0021562
patients who are symptomatically stable, as judged by the treating psychiatrist, and receive a stable dose of risperidone for a minimum of 2 weeks before enrollment.
Description

Patient status Symptomatic Stable | Risperidone Dose Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449437
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0073393
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
patients with ability to complete various questionnaires.
Description

Questionnaires Different Completion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C1705242
UMLS CUI [1,3]
C0205197
patients and/or their legal guardians/representatives who sufficiently understand the objective of the study and sign informed consent form
Description

Comprehension Study Protocol | Comprehension Study Protocol Patient Representatives | Informed Consent | Informed Consent Patient Representatives

Type de données

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0030701
UMLS CUI [3]
C0021430
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active psychotic symptoms, including severe behavioral disturbance
Description

Psychotic symptoms | Behavior disturbance Severe

Type de données

boolean

Alias
UMLS CUI [1]
C0871189
UMLS CUI [2,1]
C0149623
UMLS CUI [2,2]
C0205082
relevant history of or current presence of any significant or unstable medical disease
Description

Disease Significant | Disease Unstable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
a woman who is pregnant, breast-feeding or planning to become pregnant during the study period
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
patients with the history of serious allergy or multiple adverse drug reactions
Description

Hypersensitivity Serious | Adverse drug reactions Multiple

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0041755
UMLS CUI [2,2]
C0439064
patients with the history of taking paliperidone er within 60 days
Description

paliperidone

Type de données

boolean

Alias
UMLS CUI [1]
C0753678
patients with history of taking clozapine within 60 days
Description

Clozapine

Type de données

boolean

Alias
UMLS CUI [1]
C0009079
patients who require the treatment of other medications influencing cns, except permitted concomitant drugs in advance
Description

Requirement Pharmacotherapy Influence Central Nervous System

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C3714787
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Similar models

Eligibility Schizophrenia NCT00827840

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Inpatient
Item
patients diagnosed as schizophrenia by dsm-iv-tr criteria both in inpatients
boolean
C0036341 (UMLS CUI [1])
C0021562 (UMLS CUI [2])
Patient status Symptomatic Stable | Risperidone Dose Stable
Item
patients who are symptomatically stable, as judged by the treating psychiatrist, and receive a stable dose of risperidone for a minimum of 2 weeks before enrollment.
boolean
C0449437 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0073393 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Questionnaires Different Completion
Item
patients with ability to complete various questionnaires.
boolean
C0034394 (UMLS CUI [1,1])
C1705242 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Comprehension Study Protocol | Comprehension Study Protocol Patient Representatives | Informed Consent | Informed Consent Patient Representatives
Item
patients and/or their legal guardians/representatives who sufficiently understand the objective of the study and sign informed consent form
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0030701 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Psychotic symptoms | Behavior disturbance Severe
Item
active psychotic symptoms, including severe behavioral disturbance
boolean
C0871189 (UMLS CUI [1])
C0149623 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Disease Significant | Disease Unstable
Item
relevant history of or current presence of any significant or unstable medical disease
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
a woman who is pregnant, breast-feeding or planning to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Hypersensitivity Serious | Adverse drug reactions Multiple
Item
patients with the history of serious allergy or multiple adverse drug reactions
boolean
C0020517 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041755 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
paliperidone
Item
patients with the history of taking paliperidone er within 60 days
boolean
C0753678 (UMLS CUI [1])
Clozapine
Item
patients with history of taking clozapine within 60 days
boolean
C0009079 (UMLS CUI [1])
Requirement Pharmacotherapy Influence Central Nervous System
Item
patients who require the treatment of other medications influencing cns, except permitted concomitant drugs in advance
boolean
C1514873 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C3714787 (UMLS CUI [1,4])
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