ID

19271

Beskrivning

Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00103727

Länk

https://clinicaltrials.gov/show/NCT00103727

Nyckelord

Versioner (1)
  1. 2016-12-16 2016-12-16 -
Uppladdad den

16 december 2016

DOI

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Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00103727

Engelsk

Eligibility Schizophrenia NCT00103727

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
Beskrivning

Schizophrenia | Schizophrenia Secondary to Other medical condition | Schizophrenia Secondary to Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C3843040
UMLS CUI [3,1]
C0036341
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0038586
require inpatient hospitalization.
Beskrivning

Hospitalization Patient need for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0686904
woman may enroll only if they are not of child-bearing potential or are on a protocol-approved birth control method.
Beskrivning

Gender | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is in their first episode of schizophrenia.
Beskrivning

Schizophrenia First episode

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0439615
subject has other psychotic disorders or bipolar disorder.
Beskrivning

Psychotic Disorders | Bipolar Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0005586
subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
Beskrivning

Schizophrenia Symptoms Due to Pharmaceutical Preparations | Schizophrenia Symptoms Due to Drug abuse | Schizophrenia Symptoms Due to medical condition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0013227
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0013146
UMLS CUI [3,1]
C0036341
UMLS CUI [3,2]
C1457887
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C3843040
subject has a recent history of substance dependence/dependence, or tests positive for illicit drug.
Beskrivning

Substance Dependence | Dependence | Illicit Drugs Test Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0439857
UMLS CUI [3,1]
C0086190
UMLS CUI [3,2]
C0456984
UMLS CUI [3,3]
C1514241
subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
Beskrivning

Disease Unstable | Disease Significant | Autistic Disorder | Organic brain disorder | Liver Dysfunction | Epilepsy | Seizures | Cerebrovascular Disorders Risk Increased | Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0750502
UMLS CUI [3]
C0004352
UMLS CUI [4]
C4062280
UMLS CUI [5]
C0086565
UMLS CUI [6]
C0014544
UMLS CUI [7]
C0036572
UMLS CUI [8,1]
C0007820
UMLS CUI [8,2]
C0035647
UMLS CUI [8,3]
C0205217
UMLS CUI [9]
C0038454
subject has any significant abnormalities in any of the screening tests (ecgs, labs, physical examinations, etc.).
Beskrivning

Abnormality Significant Screening test | Electrocardiography | Laboratory Procedures | Physical Examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0871311
UMLS CUI [2]
C1623258
UMLS CUI [3]
C0022885
UMLS CUI [4]
C0031809
subject poses a current serious suicidal or homicidal risk.
Beskrivning

At risk for suicide Serious | Homicide Risk Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0019872
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0205404
subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study.
Beskrivning

Pregnancy test positive | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
subject has recently or is currently participating in another clinical study.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
subject is stabilized on their current schizophrenia treatment.
Beskrivning

Therapeutic procedure Stabilized Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0184512
UMLS CUI [1,3]
C0036341
subject needs to take any of the medicines not permitted in the study, or has recently had ect (electroconvulsive therapy) or tms (transcranial magnetic stimulation).
Beskrivning

Pharmaceutical Preparations Illicit Patient need for | Electroconvulsive Therapy | Transcranial magnetic stimulation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332266
UMLS CUI [1,3]
C0686904
UMLS CUI [2]
C0013806
UMLS CUI [3]
C0436548
subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years.
Beskrivning

Antipsychotic drug therapy Quantity Poor response to treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1319421
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1320680
subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.
Beskrivning

Allergic Reaction Investigational New Drugs | Reaction Significant Investigational New Drugs | Risperidone Intake Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0443286
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0073393
UMLS CUI [3,2]
C1512806
UMLS CUI [3,3]
C1299582
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Similar models

Eligibility Schizophrenia NCT00103727

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Schizophrenia Secondary to Other medical condition | Schizophrenia Secondary to Substance Use Disorders
Item
subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
boolean
C0036341 (UMLS CUI [1])
C0036341 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C3843040 (UMLS CUI [2,3])
C0036341 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0038586 (UMLS CUI [3,3])
Hospitalization Patient need for
Item
require inpatient hospitalization.
boolean
C0019993 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Gender | Childbearing Potential Contraceptive methods
Item
woman may enroll only if they are not of child-bearing potential or are on a protocol-approved birth control method.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Schizophrenia First episode
Item
subject is in their first episode of schizophrenia.
boolean
C0036341 (UMLS CUI [1,1])
C0439615 (UMLS CUI [1,2])
Psychotic Disorders | Bipolar Disorder
Item
subject has other psychotic disorders or bipolar disorder.
boolean
C0033975 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
Schizophrenia Symptoms Due to Pharmaceutical Preparations | Schizophrenia Symptoms Due to Drug abuse | Schizophrenia Symptoms Due to medical condition
Item
subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
boolean
C0036341 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0036341 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0013146 (UMLS CUI [2,4])
C0036341 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C3843040 (UMLS CUI [3,4])
Substance Dependence | Dependence | Illicit Drugs Test Positive
Item
subject has a recent history of substance dependence/dependence, or tests positive for illicit drug.
boolean
C0038580 (UMLS CUI [1])
C0439857 (UMLS CUI [2])
C0086190 (UMLS CUI [3,1])
C0456984 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Disease Unstable | Disease Significant | Autistic Disorder | Organic brain disorder | Liver Dysfunction | Epilepsy | Seizures | Cerebrovascular Disorders Risk Increased | Cerebrovascular accident
Item
subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0004352 (UMLS CUI [3])
C4062280 (UMLS CUI [4])
C0086565 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0036572 (UMLS CUI [7])
C0007820 (UMLS CUI [8,1])
C0035647 (UMLS CUI [8,2])
C0205217 (UMLS CUI [8,3])
C0038454 (UMLS CUI [9])
Abnormality Significant Screening test | Electrocardiography | Laboratory Procedures | Physical Examination
Item
subject has any significant abnormalities in any of the screening tests (ecgs, labs, physical examinations, etc.).
boolean
C1704258 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0871311 (UMLS CUI [1,3])
C1623258 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
At risk for suicide Serious | Homicide Risk Serious
Item
subject poses a current serious suicidal or homicidal risk.
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019872 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Pregnancy test positive | Breast Feeding | Pregnancy, Planned
Item
subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study.
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status
Item
subject has recently or is currently participating in another clinical study.
boolean
C2348568 (UMLS CUI [1])
Therapeutic procedure Stabilized Schizophrenia
Item
subject is stabilized on their current schizophrenia treatment.
boolean
C0087111 (UMLS CUI [1,1])
C0184512 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Pharmaceutical Preparations Illicit Patient need for | Electroconvulsive Therapy | Transcranial magnetic stimulation
Item
subject needs to take any of the medicines not permitted in the study, or has recently had ect (electroconvulsive therapy) or tms (transcranial magnetic stimulation).
boolean
C0013227 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0013806 (UMLS CUI [2])
C0436548 (UMLS CUI [3])
Antipsychotic drug therapy Quantity Poor response to treatment
Item
subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years.
boolean
C1319421 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [1,3])
Allergic Reaction Investigational New Drugs | Reaction Significant Investigational New Drugs | Risperidone Intake Unable
Item
subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0443286 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0073393 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
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