ID

32040

Description

Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00615433

Link

https://clinicaltrials.gov/show/NCT00615433

Keywords

Versions (1)
  1. 10/15/18 10/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 15, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00615433

English

Eligibility Schizophrenia NCT00615433

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent | Age

Data type

boolean

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

Schizophrenia Primary

Data type

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.
Description

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

Data type

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.
Description

Antipsychotic Agents Discontinue Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
good physical health on the basis of medical history, physical examination, and laboratory screening.
Description

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

Data type

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.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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).
Description

Organic disease chronic Central Nervous System | Exception Schizophrenia

Data type

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.
Description

Investigational New Drugs

Data type

boolean

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

Substance Use Disorders | Alcoholic Intoxication, Chronic | Substance Dependence

Data type

boolean

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

Eligibility Schizophrenia NCT00615433

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 Discontinue Willing
Item
able and agrees to remain off prior antipsychotic medication for the duration of study.
boolean
C0040615 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
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
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 | 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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