ID

25316

Beschrijving

Sertindole in Asian Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00864045

Link

https://clinicaltrials.gov/show/NCT00864045

Trefwoorden

Versies (1)
  1. 01-09-17 01-09-17 -
Geüploaded op

1 september 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00864045

Engels

Eligibility Schizophrenia NCT00864045

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia
Beschrijving

Age | Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0036341
positive and negative syndrome scales (panss) total score between 60 and 120 (extremes included) at screening and baseline
Beschrijving

Positive and negative syndrome scale

Datatype

boolean

Alias
UMLS CUI [1]
C0451383
based on the patient's clinical status, an antipsychotic treatment is indicated
Beschrijving

Clinical status | Indication Antipsychotic drug therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0449440
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1319421
otherwise healthy
Beschrijving

Healthy | Exception Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods
Beschrijving

Gender Childbearing Potential Lacking | Childbearing Potential Pregnancy Absent | Childbearing Potential Breast Feeding Absent | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0006147
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Axis I diagnosis Primary | Exception Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
has never before received antipsychotic drugs
Beschrijving

Antipsychotic Agents Previous Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
has received a depot antipsychotic medication within less than one dose interval prior to screening
Beschrijving

Depot antipsychotic agent

Datatype

boolean

Alias
UMLS CUI [1]
C2585377
history of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (<50 beats per minute)
Beschrijving

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

Datatype

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 in patients with known acquired qt interval prolongation (qtc above 450 msec in males and 470 msec in females at screening)
Beschrijving

Congenital long QT syndrome | Family history of long QT syndrome | Prolonged QT interval Acquired | QTc | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C1141890
UMLS CUI [2]
C3839836
UMLS CUI [3,1]
C0151878
UMLS CUI [3,2]
C0439661
UMLS CUI [4]
C0860814
UMLS CUI [5]
C0079399
significant risk of suicide and/or violent behaviour
Beschrijving

At risk for suicide | At risk for violence

Datatype

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C0231418
known history of narrow angle glaucoma
Beschrijving

Angle Closure Glaucoma

Datatype

boolean

Alias
UMLS CUI [1]
C0017605
substance or alcohol abuse, current alcohol dependence
Beschrijving

Substance Use Disorders | Alcoholic Intoxication, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0001973
use of disallowed concomitant medication
Beschrijving

Illicit drug use

Datatype

boolean

Alias
UMLS CUI [1]
C0281875
other protocol-defined inclusion and exclusion criteria may apply.
Beschrijving

Clinical Trial Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Schizophrenia NCT00864045

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Schizophrenia
Item
male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia
boolean
C0001779 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Positive and negative syndrome scale
Item
positive and negative syndrome scales (panss) total score between 60 and 120 (extremes included) at screening and baseline
boolean
C0451383 (UMLS CUI [1])
Clinical status | Indication Antipsychotic drug therapy
Item
based on the patient's clinical status, an antipsychotic treatment is indicated
boolean
C0449440 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C1319421 (UMLS CUI [2,2])
Healthy | Exception Schizophrenia
Item
otherwise healthy
boolean
C3898900 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Gender Childbearing Potential Lacking | Childbearing Potential Pregnancy Absent | Childbearing Potential Breast Feeding Absent | Childbearing Potential Contraceptive methods
Item
female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0006147 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
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 Previous Absent
Item
has never before received antipsychotic drugs
boolean
C0040615 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Depot antipsychotic agent
Item
has received a depot antipsychotic medication within less than one dose interval prior to screening
boolean
C2585377 (UMLS CUI [1])
Cardiovascular Diseases | Congestive heart failure | Cardiac Hypertrophy | Cardiac Arrhythmia | Bradycardia
Item
history of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (<50 beats per minute)
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 of long QT syndrome | Prolonged QT interval Acquired | QTc | Gender
Item
congenital long qt syndrome or a family history of this disease, or in patients with known acquired qt interval prolongation (qtc above 450 msec in males and 470 msec in females at screening)
boolean
C1141890 (UMLS CUI [1])
C3839836 (UMLS CUI [2])
C0151878 (UMLS CUI [3,1])
C0439661 (UMLS CUI [3,2])
C0860814 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
At risk for suicide | At risk for violence
Item
significant risk of suicide and/or violent behaviour
boolean
C0563664 (UMLS CUI [1])
C0231418 (UMLS CUI [2])
Angle Closure Glaucoma
Item
known history of narrow angle glaucoma
boolean
C0017605 (UMLS CUI [1])
Substance Use Disorders | Alcoholic Intoxication, Chronic
Item
substance or alcohol abuse, current alcohol dependence
boolean
C0038586 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
Illicit drug use
Item
use of disallowed concomitant medication
boolean
C0281875 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion and exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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