ID

23822

Descrizione

A Double-blind, Placebo-controlled Study of the Safety and Efficacy of Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in Adolescent Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00518323

collegamento

https://clinicaltrials.gov/show/NCT00518323

Keywords

  1. 14/07/17 14/07/17 -
Caricato su

14 luglio 2017

DOI

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Licenza

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT00518323

Eligibility Schizophrenia NCT00518323

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
must meet the diagnostic and statistical manual of mental disorders, 4th edition (dsm iv) criteria for schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) for 1 year (the diagnosis will be established using the k-sads-pl, including all supplements)
Descrizione

ID.1

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0036341
must not be a danger to themselves or others, and must have family support available to be maintained as an outpatient
Descrizione

ID.2

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0549013
UMLS CUI [1,3]
C0150232
should have had at least 1 adequate treatment with an antipsychotic before participation in this study
Descrizione

ID.3

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0040615
must have a panss score between 60 and 120, inclusive, at screening and baseline
Descrizione

ID.4

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0451383
weight >=29 kg
Descrizione

ID.5

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
meet the dsm-iv criteria at screening for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance induced psychotic disorder. other comorbid disorders e.g., attention-deficit hyperactivity disorder (adhd) are allowed as long as the diagnosis of schizophrenia is the primary diagnosis and the comorbid disorders in the investigator's judgment do not require medication
Descrizione

ID.6

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2199206
mild, moderate, or severe mental retardation (i.e., documented intelligence quotient [iq] <70) established by previous iq testing or history
Descrizione

ID.7

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0025362
women who are pregnant (as confirmed by urine pregnancy test performed at screening or baseline), planning to become pregnant or are nursing
Descrizione

ID.8

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
have a known or suspected history of seizure disorder, or neuroleptic malignant syndrome, encephalopathic syndrome, tardive dyskinesia, or insulin dependent diabetes mellitus
Descrizione

ID.9

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0027849
UMLS CUI [1,3]
C0686347
UMLS CUI [1,4]
C0011854
presence of any significant or unstable cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
Descrizione

ID.10

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0012634

Similar models

Eligibility Schizophrenia NCT00518323

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
must meet the diagnostic and statistical manual of mental disorders, 4th edition (dsm iv) criteria for schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) for 1 year (the diagnosis will be established using the k-sads-pl, including all supplements)
boolean
C0036341 (UMLS CUI [1])
ID.2
Item
must not be a danger to themselves or others, and must have family support available to be maintained as an outpatient
boolean
C0036341 (UMLS CUI [1,1])
C0549013 (UMLS CUI [1,2])
C0150232 (UMLS CUI [1,3])
ID.3
Item
should have had at least 1 adequate treatment with an antipsychotic before participation in this study
boolean
C0040615 (UMLS CUI [1])
ID.4
Item
must have a panss score between 60 and 120, inclusive, at screening and baseline
boolean
C0451383 (UMLS CUI [1])
ID.5
Item
weight >=29 kg
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
meet the dsm-iv criteria at screening for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance induced psychotic disorder. other comorbid disorders e.g., attention-deficit hyperactivity disorder (adhd) are allowed as long as the diagnosis of schizophrenia is the primary diagnosis and the comorbid disorders in the investigator's judgment do not require medication
boolean
C2199206 (UMLS CUI [1])
ID.7
Item
mild, moderate, or severe mental retardation (i.e., documented intelligence quotient [iq] <70) established by previous iq testing or history
boolean
C0025362 (UMLS CUI [1])
ID.8
Item
women who are pregnant (as confirmed by urine pregnancy test performed at screening or baseline), planning to become pregnant or are nursing
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.9
Item
have a known or suspected history of seizure disorder, or neuroleptic malignant syndrome, encephalopathic syndrome, tardive dyskinesia, or insulin dependent diabetes mellitus
boolean
C0014544 (UMLS CUI [1,1])
C0027849 (UMLS CUI [1,2])
C0686347 (UMLS CUI [1,3])
C0011854 (UMLS CUI [1,4])
ID.10
Item
presence of any significant or unstable cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
boolean
C0012634 (UMLS CUI [1])

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