ID

16723

Descrição

Memantine for the Treatment of Negative Symptomatology; ODM derived from: https://clinicaltrials.gov/show/NCT00148616

Link

https://clinicaltrials.gov/show/NCT00148616

Palavras-chave

  1. 02/08/2016 02/08/2016 -
Transferido a

2 de agosto de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Chronic Schizophrenia NCT00148616

Eligibility Chronic Schizophrenia NCT00148616

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of schizophrenia (dsm-iv)
Descrição

Schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
age 18 to 40
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
stable negative syndrome (panss negative score > 20)
Descrição

Syndrome Negative Stable | Positive and negative syndrome scale

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0039082
UMLS CUI [1,2]
C0205160
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0451383
at least one previous schizophrenic episode
Descrição

schizophrenic episode Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0813173
UMLS CUI [1,2]
C1265611
informed consent
Descrição

Informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
subjects must be considered by the investigator to be compliant with investigations and appointments
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
subjects must have an educational level and a degree of understanding such that they can meaningfully communicate with the investigator
Descrição

Educational Status | Comprehension | Able to communicate Investigator

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013658
UMLS CUI [2]
C0162340
UMLS CUI [3,1]
C2364293
UMLS CUI [3,2]
C2826892
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
axis i disorder other than schizophrenia within 12 months, e.g. schizoaffective disorder
Descrição

Axis I diagnosis | Schizophrenia | Schizoaffective Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0036337
severe positive symptomatology (panns positive score > panns negative score)
Descrição

Symptoms Positive Severe | Positive and negative syndrome scale

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1446409
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C0451383
dependency on alcohol or addictive drugs within 6 months of the baseline evaluation
Descrição

Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038580
contraindication of risperidone
Descrição

Medical contraindication Risperidone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0073393
significant neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests
Descrição

nervous system disorder Significant | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Metabolic Diseases | LABORATORY ABNORMALITIES Relevant Clinical

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0025517
UMLS CUI [6,1]
C1853129
UMLS CUI [6,2]
C2347946
UMLS CUI [6,3]
C0205210

Similar models

Eligibility Chronic Schizophrenia NCT00148616

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
diagnosis of schizophrenia (dsm-iv)
boolean
C0036341 (UMLS CUI [1])
Age
Item
age 18 to 40
boolean
C0001779 (UMLS CUI [1])
Syndrome Negative Stable | Positive and negative syndrome scale
Item
stable negative syndrome (panss negative score > 20)
boolean
C0039082 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0451383 (UMLS CUI [2])
schizophrenic episode Quantity
Item
at least one previous schizophrenic episode
boolean
C0813173 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
subjects must be considered by the investigator to be compliant with investigations and appointments
boolean
C0525058 (UMLS CUI [1])
Educational Status | Comprehension | Able to communicate Investigator
Item
subjects must have an educational level and a degree of understanding such that they can meaningfully communicate with the investigator
boolean
C0013658 (UMLS CUI [1])
C0162340 (UMLS CUI [2])
C2364293 (UMLS CUI [3,1])
C2826892 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Schizophrenia | Schizoaffective Disorder
Item
axis i disorder other than schizophrenia within 12 months, e.g. schizoaffective disorder
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
Symptoms Positive Severe | Positive and negative syndrome scale
Item
severe positive symptomatology (panns positive score > panns negative score)
boolean
C1457887 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0451383 (UMLS CUI [2])
Substance Dependence
Item
dependency on alcohol or addictive drugs within 6 months of the baseline evaluation
boolean
C0038580 (UMLS CUI [1])
Medical contraindication Risperidone
Item
contraindication of risperidone
boolean
C1301624 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
nervous system disorder Significant | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Metabolic Diseases | LABORATORY ABNORMALITIES Relevant Clinical
Item
significant neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests
boolean
C0027765 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C1853129 (UMLS CUI [6,1])
C2347946 (UMLS CUI [6,2])
C0205210 (UMLS CUI [6,3])

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