ID

19257

Descripción

Safety Study With Paliperidone ER Extended-Release (ER) Tablets in Geriatric Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00085748

Link

https://clinicaltrials.gov/show/NCT00085748

Palabras clave

Versiones (1)
  1. 15/12/16 15/12/16 -
Subido en

15 de diciembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00085748

Inglés

Eligibility Schizophrenia NCT00085748

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
double-blind phase: 65 years of age or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
dsm-iv diagnosis of schizophrenia for at least 1 year
Descripción

Schizophrenia disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
total panss score at screening and baseline between 70 and 120, inclusive
Descripción

Positive and negative syndrome scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451383
agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated
Descripción

Hospitalization Duration Agreement | Indication Hospitalization Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0680240
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0019993
UMLS CUI [2,3]
C0449238
open-label treatment phase: completed 6 weeks of the double-blind treatment phase or finished at least 21 days of treatment and discontinued because of lack of efficacy.
Descripción

Therapeutic procedure Double-Blind Method Complete | Therapeutic procedure Discontinued Lack of Efficacy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013072
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0235828
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
dsm-iv axis i diagnosis other than schizophrenia
Descripción

Axis I diagnosis | Schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0036341
dsm-iv diagnosis of substance dependence within the 6 months before screening (nicotine and caffeine dependence are not exclusionary)
Descripción

Substance Dependence | Nicotine Dependence | Caffeine dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
history of tardive dyskinesia or neuroleptic malignant syndrome (nms)
Descripción

Tardive Dyskinesia | Neuroleptic Malignant Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2]
C0027849
history of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
Descripción

Gastrointestinal stenosis Pathologic Pre-existing Severe | Gastrointestinal stenosis Iatrogenic Pre-existing Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0521587
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C2347662
UMLS CUI [1,4]
C0205082
UMLS CUI [2,1]
C0521587
UMLS CUI [2,2]
C0439669
UMLS CUI [2,3]
C2347662
UMLS CUI [2,4]
C0205082
previous history of a lack of response (2 adequate trials) to any antipsychotic
Descripción

Antipsychotic Agents Quantity | Poor response to treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1320680
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Similar models

Eligibility Schizophrenia NCT00085748

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
double-blind phase: 65 years of age or older
boolean
C0001779 (UMLS CUI [1])
Schizophrenia disease length
Item
dsm-iv diagnosis of schizophrenia for at least 1 year
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Positive and negative syndrome scale
Item
total panss score at screening and baseline between 70 and 120, inclusive
boolean
C0451383 (UMLS CUI [1])
Hospitalization Duration Agreement | Indication Hospitalization Duration
Item
agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Therapeutic procedure Double-Blind Method Complete | Therapeutic procedure Discontinued Lack of Efficacy
Item
open-label treatment phase: completed 6 weeks of the double-blind treatment phase or finished at least 21 days of treatment and discontinued because of lack of efficacy.
boolean
C0087111 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0235828 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Schizophrenia
Item
dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
dsm-iv diagnosis of substance dependence within the 6 months before screening (nicotine and caffeine dependence are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Tardive Dyskinesia | Neuroleptic Malignant Syndrome
Item
history of tardive dyskinesia or neuroleptic malignant syndrome (nms)
boolean
C0686347 (UMLS CUI [1])
C0027849 (UMLS CUI [2])
Gastrointestinal stenosis Pathologic Pre-existing Severe | Gastrointestinal stenosis Iatrogenic Pre-existing Severe
Item
history of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
boolean
C0521587 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0521587 (UMLS CUI [2,1])
C0439669 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
Antipsychotic Agents Quantity | Poor response to treatment
Item
previous history of a lack of response (2 adequate trials) to any antipsychotic
boolean
C0040615 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [2])
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