ID

32124

Description

Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants; ODM derived from: https://clinicaltrials.gov/show/NCT00784238

Link

https://clinicaltrials.gov/show/NCT00784238

Keywords

Versions (1)
  1. 10/19/18 10/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00784238

English

Eligibility Schizophrenia NCT00784238

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants who are diagnosed with schizophrenia (diagnosis criteria: diagnostic and statistical manual of mental disorders, fourth edition [dsm-iv])
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening-lack of efficacy, lack of tolerance or lack of compliance
Description

Patient need for Change Antipsychotic Agent | Etiology aspects | Lack of Efficacy | Intolerance to substance | Medication Compliance Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0040615
UMLS CUI [2]
C0015127
UMLS CUI [3]
C0235828
UMLS CUI [4]
C1744706
UMLS CUI [5,1]
C3489773
UMLS CUI [5,2]
C0332268
participants who are capable of and willing to fill out the questionnaire for themselves
Description

Questionnaire Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
Description

Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3]
C1656586
UMLS CUI [4]
C0021900
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C0205173
UMLS CUI [6]
C2985284
participants who are compliant with self-medication or can receive consistent help or support
Description

Compliance behavior Self Medication | Ability Receive Support

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0036600
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1521721
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with the past history of neuroleptic malignant syndrome (nms), or with allergy or hypersensitivity to risperidone or paliperidone
Description

Neuroleptic Malignant Syndrome | Risperidone allergy | Hypersensitivity paliperidone

Data type

boolean

Alias
UMLS CUI [1]
C0027849
UMLS CUI [2]
C0570837
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0753678
participants who have taken clozapine within one month before screening
Description

Clozapine

Data type

boolean

Alias
UMLS CUI [1]
C0009079
participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
Description

At risk for suicide | At risk Aggressive behavior | Completion of clinical trial Unable

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0001807
UMLS CUI [3,1]
C2732579
UMLS CUI [3,2]
C1299582
participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (the study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile)
Description

Gastrointestinal stenosis Severe Pre-existing | Gastrointestinal stenosis Severe Pre-existing Iatrogenic | Lacking Able to swallow Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0521587
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2347662
UMLS CUI [2,1]
C0521587
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2347662
UMLS CUI [2,4]
C0439669
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2712086
UMLS CUI [3,3]
C0013230
participants with a known or suspected history (for 6 months and longer) of substance dependence according to the dsm-iv criteria
Description

Substance Dependence | Substance Dependence Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C0750491
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Similar models

Eligibility Schizophrenia NCT00784238

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
participants who are diagnosed with schizophrenia (diagnosis criteria: diagnostic and statistical manual of mental disorders, fourth edition [dsm-iv])
boolean
C0036341 (UMLS CUI [1])
Patient need for Change Antipsychotic Agent | Etiology aspects | Lack of Efficacy | Intolerance to substance | Medication Compliance Lacking
Item
participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening-lack of efficacy, lack of tolerance or lack of compliance
boolean
C0686904 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0040615 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2])
C0235828 (UMLS CUI [3])
C1744706 (UMLS CUI [4])
C3489773 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
Questionnaire Completion
Item
participants who are capable of and willing to fill out the questionnaire for themselves
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch
Item
childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C1656586 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C2985284 (UMLS CUI [6])
Compliance behavior Self Medication | Ability Receive Support
Item
participants who are compliant with self-medication or can receive consistent help or support
boolean
C1321605 (UMLS CUI [1,1])
C0036600 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1521721 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Neuroleptic Malignant Syndrome | Risperidone allergy | Hypersensitivity paliperidone
Item
participants with the past history of neuroleptic malignant syndrome (nms), or with allergy or hypersensitivity to risperidone or paliperidone
boolean
C0027849 (UMLS CUI [1])
C0570837 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0753678 (UMLS CUI [3,2])
Clozapine
Item
participants who have taken clozapine within one month before screening
boolean
C0009079 (UMLS CUI [1])
At risk for suicide | At risk Aggressive behavior | Completion of clinical trial Unable
Item
participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
boolean
C0563664 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0001807 (UMLS CUI [2,2])
C2732579 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Gastrointestinal stenosis Severe Pre-existing | Gastrointestinal stenosis Severe Pre-existing Iatrogenic | Lacking Able to swallow Investigational New Drug
Item
participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (the study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile)
boolean
C0521587 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0521587 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C0439669 (UMLS CUI [2,4])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
Substance Dependence | Substance Dependence Suspected
Item
participants with a known or suspected history (for 6 months and longer) of substance dependence according to the dsm-iv criteria
boolean
C0038580 (UMLS CUI [1])
C0038580 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
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