ID

32182

Descripción

An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01009047

Link

https://clinicaltrials.gov/show/NCT01009047

Palabras clave

Versiones (1)
  1. 23/10/18 23/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01009047

Inglés

Eligibility Schizophrenia NCT01009047

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must currently meet the diagnostic and statistical manual of mental disorders fourth edition (dsm-iv) criteria for schizophrenia and have experienced symptoms of the illness for at least 1 year, and they should have had at least treatment with 1 antipsychotic before participation in this study
Descripción

Schizophrenia | Symptoms Schizophrenia Duration | Antipsychotic Agents Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0036341
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C1265611
participants having a positive and negative syndromes scale (panss) score between 60 and 120 inclusive at screening
Descripción

Positive and Negative Syndrome Scale Clinical Classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4086747
female participants must be incapable of pregnancy, or if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception for at least 1 month before study entry and agree to continue use contraception methods for the duration of the study, or if sexually abstinent (not having sexual intercourse) and capable of pregnancy, must agree to continue abstinence or to use an acceptable method of birth control
Descripción

Gender Infertility | Childbearing Potential Sexually active Contraceptive methods | Childbearing Potential Sexual Abstinence | Childbearing Potential Sexual Abstinence Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0021359
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [4,3]
C0700589
participants must not be a danger to themselves or others, and must have family support available to be maintained as out-patients
Descripción

DANGER OF HARM TO SELF Absent | At risk of harming others Absent | Family support Available

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0149660
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1271966
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0150232
UMLS CUI [3,2]
C0470187
participants with a weight of equal to or greater than 29 kilogram
Descripción

Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with mild (not serious), moderate (medium level of seriousness), or severe (very serious, life threatening) mental retardation
Descripción

Mild Mental Retardation | Moderate mental retardation | Severe mental retardation | Mental Retardation Life Threatening

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026106
UMLS CUI [2]
C0026351
UMLS CUI [3]
C0036857
UMLS CUI [4,1]
C0025362
UMLS CUI [4,2]
C2826244
participants with a known or suspected history of substance dependence (including alcohol, but excluding nicotine or caffeine) as per the dsm-iv criteria in the 3 months before screening
Descripción

Substance Dependence | Substance Dependence Suspected | Exception Nicotine Dependence | Exception Caffeine dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028043
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1386553
participants with a history of certain neurological (pertaining to the nervous system) disorders or insulin-dependent diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects)
Descripción

Nervous system disorder | Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0011854
participants who have received a depot injectable antipsychotic within 2 treatment cycles before the screening visit
Descripción

Injection of depot antipsychotic agent | Treatment Course Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2585377
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
participants who have received clozapine in 2 months before the baseline visit (day 1 of week 1)
Descripción

Clozapine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009079
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Similar models

Eligibility Schizophrenia NCT01009047

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Symptoms Schizophrenia Duration | Antipsychotic Agents Quantity
Item
participants must currently meet the diagnostic and statistical manual of mental disorders fourth edition (dsm-iv) criteria for schizophrenia and have experienced symptoms of the illness for at least 1 year, and they should have had at least treatment with 1 antipsychotic before participation in this study
boolean
C0036341 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0040615 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Positive and Negative Syndrome Scale Clinical Classification
Item
participants having a positive and negative syndromes scale (panss) score between 60 and 120 inclusive at screening
boolean
C4086747 (UMLS CUI [1])
Gender Infertility | Childbearing Potential Sexually active Contraceptive methods | Childbearing Potential Sexual Abstinence | Childbearing Potential Sexual Abstinence Contraceptive methods
Item
female participants must be incapable of pregnancy, or if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception for at least 1 month before study entry and agree to continue use contraception methods for the duration of the study, or if sexually abstinent (not having sexual intercourse) and capable of pregnancy, must agree to continue abstinence or to use an acceptable method of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0021359 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
DANGER OF HARM TO SELF Absent | At risk of harming others Absent | Family support Available
Item
participants must not be a danger to themselves or others, and must have family support available to be maintained as out-patients
boolean
C0149660 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1271966 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0150232 (UMLS CUI [3,1])
C0470187 (UMLS CUI [3,2])
Body Weight
Item
participants with a weight of equal to or greater than 29 kilogram
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mild Mental Retardation | Moderate mental retardation | Severe mental retardation | Mental Retardation Life Threatening
Item
participants with mild (not serious), moderate (medium level of seriousness), or severe (very serious, life threatening) mental retardation
boolean
C0026106 (UMLS CUI [1])
C0026351 (UMLS CUI [2])
C0036857 (UMLS CUI [3])
C0025362 (UMLS CUI [4,1])
C2826244 (UMLS CUI [4,2])
Substance Dependence | Substance Dependence Suspected | Exception Nicotine Dependence | Exception Caffeine dependence
Item
participants with a known or suspected history of substance dependence (including alcohol, but excluding nicotine or caffeine) as per the dsm-iv criteria in the 3 months before screening
boolean
C0038580 (UMLS CUI [1])
C0038580 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0028043 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1386553 (UMLS CUI [4,2])
Nervous system disorder | Diabetes Mellitus, Insulin-Dependent
Item
participants with a history of certain neurological (pertaining to the nervous system) disorders or insulin-dependent diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects)
boolean
C0027765 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
Injection of depot antipsychotic agent | Treatment Course Quantity
Item
participants who have received a depot injectable antipsychotic within 2 treatment cycles before the screening visit
boolean
C2585377 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Clozapine
Item
participants who have received clozapine in 2 months before the baseline visit (day 1 of week 1)
boolean
C0009079 (UMLS CUI [1])
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