ID

32135

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00827840

Palavras-chave

Versões (1)
  1. 20/10/2018 20/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00827840

Inglês

Eligibility Schizophrenia NCT00827840

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Schizophrenia | Inpatient

Tipo de dados

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.
Descrição

Patient status Symptomatic Stable | Risperidone Dose Stable

Tipo de dados

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.
Descrição

Questionnaires Different Completion

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Exclusion Criteria

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

Psychotic symptoms | Behavior disturbance Severe

Tipo de dados

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
Descrição

Disease Significant | Disease Unstable

Tipo de dados

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
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

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
Descrição

Hypersensitivity Serious | Adverse drug reactions Multiple

Tipo de dados

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
Descrição

paliperidone

Tipo de dados

boolean

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

Clozapine

Tipo de dados

boolean

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

Requirement Pharmacotherapy Influence Central Nervous System

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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