ID

32023

Descrizione

Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00549718

collegamento

https://clinicaltrials.gov/show/NCT00549718

Keywords

versioni (1)
  1. 13/10/18 13/10/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

13 ottobre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00549718

Inglese

Eligibility Schizophrenia NCT00549718

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be eligible to enter the study, each patient must comply with the following inclusion criteria:
Descrizione

Inclusion criteria Fulfill

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
provide written informed consent and aged between 18 and 75 years of age.
Descrizione

Informed Consent | Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0001779
meets dsm-iv™ criteria for a primary diagnosis of schizophrenia.
Descrizione

Schizophrenia Primary

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0205225
not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
Descrizione

Pregnancy Absent | Reproductive potential Sexual Abstinence | Reproductive potential Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
able and agrees to remain off prior antipsychotic medication for the duration of study.
Descrizione

Antipsychotic Agents To be stopped

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1272691
good physical health on the basis of medical history, physical examination, and laboratory screening.
Descrizione

Physical Well-being Medical History | Physical Well-being Physical Examination | Physical Well-being Laboratory Screening

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0517226
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0517226
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C0517226
UMLS CUI [3,2]
C4542589
willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
Descrizione

Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Descrizione

At risk for suicide | At risk for deliberate self harm | Risk of violence or harm to others | At risk for destructive behavior to property

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C1276053
UMLS CUI [3]
C0549013
UMLS CUI [4]
C2584565
any chronic organic disease of the cns (other than schizophrenia)
Descrizione

Organic disease chronic Central Nervous System | Exception Schizophrenia

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0683324
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C3714787
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
used investigational compound within 30 days.
Descrizione

Compound Investigational

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1706082
UMLS CUI [1,2]
C1517586
clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Descrizione

Substance Use Disorders | Alcoholic Intoxication, Chronic | Substance Dependence

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0001973
UMLS CUI [3]
C0038580
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Similar models

Eligibility Schizophrenia NCT00549718

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Fulfill
Item
to be eligible to enter the study, each patient must comply with the following inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Informed Consent | Age
Item
provide written informed consent and aged between 18 and 75 years of age.
boolean
C0021430 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Schizophrenia Primary
Item
meets dsm-iv™ criteria for a primary diagnosis of schizophrenia.
boolean
C0036341 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Pregnancy Absent | Reproductive potential Sexual Abstinence | Reproductive potential Contraceptive methods
Item
not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4034483 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Antipsychotic Agents To be stopped
Item
able and agrees to remain off prior antipsychotic medication for the duration of study.
boolean
C0040615 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Physical Well-being Medical History | Physical Well-being Physical Examination | Physical Well-being Laboratory Screening
Item
good physical health on the basis of medical history, physical examination, and laboratory screening.
boolean
C0517226 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0517226 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0517226 (UMLS CUI [3,1])
C4542589 (UMLS CUI [3,2])
Protocol Compliance
Item
willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
At risk for suicide | At risk for deliberate self harm | Risk of violence or harm to others | At risk for destructive behavior to property
Item
considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
boolean
C0563664 (UMLS CUI [1])
C1276053 (UMLS CUI [2])
C0549013 (UMLS CUI [3])
C2584565 (UMLS CUI [4])
Organic disease chronic Central Nervous System | Exception Schizophrenia
Item
any chronic organic disease of the cns (other than schizophrenia)
boolean
C0683324 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Compound Investigational
Item
used investigational compound within 30 days.
boolean
C1706082 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Substance Use Disorders | Alcoholic Intoxication, Chronic | Substance Dependence
Item
clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
boolean
C0038586 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
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