ID

32023

Description

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

Link

https://clinicaltrials.gov/show/NCT00549718

Keywords

Versions (1)
  1. 10/13/18 10/13/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 13, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Schizophrenia NCT00549718

English

Eligibility Schizophrenia NCT00549718

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Inclusion criteria Fulfill

Data type

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.
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 | Reproductive potential Sexual Abstinence | Reproductive potential Contraceptive methods

Data type

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.
Description

Antipsychotic Agents To be stopped

Data type

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.
Description

Physical Well-being Medical History | Physical Well-being Physical Examination | Physical Well-being 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 | Risk of violence or harm to others | At risk for destructive behavior to property

Data type

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)
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

Compound Investigational

Data type

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.
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
Back to the top of the page

Similar models

Eligibility Schizophrenia NCT00549718

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial