ID

32125

Beskrivning

Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.; ODM derived from: https://clinicaltrials.gov/show/NCT00790192

Länk

https://clinicaltrials.gov/show/NCT00790192

Nyckelord

Versioner (1)
  1. 2018-10-19 2018-10-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00790192

Engelsk

Eligibility Schizophrenia NCT00790192

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
provide written informed consent and aged between 18 and 75 years of age.
Beskrivning

Informed Consent | Age

Datatyp

boolean

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

Schizophrenia Primary

Datatyp

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.
Beskrivning

Pregnancy Absent | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
able and agrees to remain off prior antipsychotic medication for the duration of study.
Beskrivning

Antipsychotic Agents Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0332197
good physical health on the basis of medical history, physical examination, and laboratory screening.
Beskrivning

Physical health Medical History | Physical health Physical Examination | Physical health Laboratory Screening

Datatyp

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.
Beskrivning

Protocol Compliance | Inpatient Requirement | Outpatient Clinic Visits

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0021562
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C0029921
UMLS CUI [3,2]
C0008952
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

At risk for suicide | At risk for deliberate self harm | At risk of harming others | At risk for destructive behavior to property

Datatyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C1276053
UMLS CUI [3]
C1271966
UMLS CUI [4]
C2584565
any chronic organic disease of the cns (other than schizophrenia).
Beskrivning

Organic disease chronic Central Nervous System | Exception Schizophrenia

Datatyp

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.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Beskrivning

Substance Use Disorders | Alcoholic Intoxication, Chronic | Substance Dependence

Datatyp

boolean

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

Eligibility Schizophrenia NCT00790192

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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 | Childbearing Potential Sexual Abstinence | Childbearing 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])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Antipsychotic Agents Absent
Item
able and agrees to remain off prior antipsychotic medication for the duration of study.
boolean
C0040615 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Physical health Medical History | Physical health Physical Examination | Physical health 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 | Inpatient Requirement | Outpatient Clinic Visits
Item
willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
boolean
C0525058 (UMLS CUI [1])
C0021562 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0029921 (UMLS CUI [3,1])
C0008952 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
At risk for suicide | At risk for deliberate self harm | At risk of harming 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])
C1271966 (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])
Investigational New Drugs
Item
used investigational compound within 30 days.
boolean
C0013230 (UMLS CUI [1])
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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