Informações:
Falhas:
ID
23822
Descrição
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
Link
https://clinicaltrials.gov/show/NCT00518323
Palavras-chave
Versões (1)
- 14/07/2017 14/07/2017 -
Transferido a
14 de julho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00518323
Eligibility Schizophrenia NCT00518323
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT00518323
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])