ID

44279

Description

Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00654706

Link

https://clinicaltrials.gov/show/NCT00654706

Keywords

Versions (2)
  1. 10/22/18 10/22/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00654706

English

Eligibility Schizophrenia NCT00654706

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary diagnosis of schizophrenia
Description

Schizophrenia Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0205225
man or woman, aged between 18 and 55 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current axis i primary psychiatric diagnosis other than schizophrenia
Description

Axis I diagnosis Primary | Exception Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
not previously received antipsychotic drugs for schizophrenia
Description

Antipsychotic Agents Absent Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0036341
acute exacerbation requiring hospitalisation within the last 3 months
Description

Exacerbation acute Hospitalization Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0743630
UMLS CUI [1,2]
C1708385
clinically significant extrapyramidal symptoms
Description

Extrapyramidal sign

Data type

boolean

Alias
UMLS CUI [1]
C0234133
clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia
Description

Cardiovascular Disease | Congestive heart failure | Cardiac Hypertrophy | Cardiac Arrhythmia | Bradycardia

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0018802
UMLS CUI [3]
C1383860
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0428977
congenital long qt syndrome or a family history of this disease, or known acquired qt interval prolongation
Description

Congenital long QT syndrome | Family history Congenital long QT syndrome | Prolonged QT interval Acquired

Data type

boolean

Alias
UMLS CUI [1]
C1141890
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C1141890
UMLS CUI [3,1]
C0151878
UMLS CUI [3,2]
C0439661
significant ecg abnormalities
Description

ECG abnormality

Data type

boolean

Alias
UMLS CUI [1]
C0522055
hypokalaemia or hypomagnesaemia
Description

Hypokalemia | Hypomagnesemia

Data type

boolean

Alias
UMLS CUI [1]
C0020621
UMLS CUI [2]
C0151723
in concurrent treatment with drugs inhibiting the p450 enzymes system cyp3a
Description

CYP3A Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3850056
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Similar models

Eligibility Schizophrenia NCT00654706

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia Primary
Item
primary diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Age
Item
man or woman, aged between 18 and 55 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis Primary | Exception Schizophrenia
Item
current axis i primary psychiatric diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Antipsychotic Agents Absent Schizophrenia
Item
not previously received antipsychotic drugs for schizophrenia
boolean
C0040615 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Exacerbation acute Hospitalization Required
Item
acute exacerbation requiring hospitalisation within the last 3 months
boolean
C0743630 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Extrapyramidal sign
Item
clinically significant extrapyramidal symptoms
boolean
C0234133 (UMLS CUI [1])
Cardiovascular Disease | Congestive heart failure | Cardiac Hypertrophy | Cardiac Arrhythmia | Bradycardia
Item
clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1383860 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0428977 (UMLS CUI [5])
Congenital long QT syndrome | Family history Congenital long QT syndrome | Prolonged QT interval Acquired
Item
congenital long qt syndrome or a family history of this disease, or known acquired qt interval prolongation
boolean
C1141890 (UMLS CUI [1])
C0241889 (UMLS CUI [2,1])
C1141890 (UMLS CUI [2,2])
C0151878 (UMLS CUI [3,1])
C0439661 (UMLS CUI [3,2])
ECG abnormality
Item
significant ecg abnormalities
boolean
C0522055 (UMLS CUI [1])
Hypokalemia | Hypomagnesemia
Item
hypokalaemia or hypomagnesaemia
boolean
C0020621 (UMLS CUI [1])
C0151723 (UMLS CUI [2])
CYP3A Inhibitors
Item
in concurrent treatment with drugs inhibiting the p450 enzymes system cyp3a
boolean
C3850056 (UMLS CUI [1])
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