ID

22714

Description

Study to Measure Drug Satisfaction of Patients With Schizophrenia After Switching From Risperidone to Paliperidone; ODM derived from: https://clinicaltrials.gov/show/NCT00535132

Link

https://clinicaltrials.gov/show/NCT00535132

Keywords

  1. 6/10/17 6/10/17 -
Uploaded on

June 10, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT00535132

Eligibility Schizophrenia NCT00535132

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be able to understand, in the opinion of the investigator, the informed consent form.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
be diagnosed with schizophrenia
Description

schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
report dissatisfaction with current medication
Description

report dissatisfaction with current medication

Data type

boolean

Alias
UMLS CUI [1]
C4049186
have an aspect of schizophrenia management which could potentially benefit from a change in antipsychotic medication
Description

schizophrenia management, benefit from a change in antipsychotic medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0376636
UMLS CUI [2,1]
C0814225
UMLS CUI [2,2]
C0580105
UMLS CUI [2,3]
C0040615
receive risperidone 4 mg or 6 mg for at least 4 weeks before the start of the study.
Description

risperidone duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to swallow study drug whole with the aid of water
Description

ability to swallow study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0566355
UMLS CUI [1,2]
C0304229
cannot have received an investigational drug, used an investigational medical device, or participated in a clinical study that altered their medication within 6 months before the first administration of study drug, or have participated in more than 2 investigational drug studies within the past 12 months
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
no other major mental health diagnosis except for tobacco dependance
Description

other mental disorders, except for tobacco dependance

Data type

boolean

Alias
UMLS CUI [1]
C0338607
UMLS CUI [2]
C0543414
no use of cocaine or heroin within 3 months before the first administration
Description

cocaine, heroin

Data type

boolean

Alias
UMLS CUI [1]
C0009170
UMLS CUI [2]
C0011892
no history of treatment with any antipsychotic in addition to treatment with risperidone, or treatment with paliperidone, within 30 days before the baseline visit.
Description

no prior therapy with any antipsychotic, treatment with risperidone, treatment with paliperidone

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0040615
UMLS CUI [1,3]
C0073393
UMLS CUI [1,4]
C0753678

Similar models

Eligibility Schizophrenia NCT00535132

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
must be able to understand, in the opinion of the investigator, the informed consent form.
boolean
C0021430 (UMLS CUI [1])
schizophrenia
Item
be diagnosed with schizophrenia
boolean
C0036341 (UMLS CUI [1])
report dissatisfaction with current medication
Item
report dissatisfaction with current medication
boolean
C4049186 (UMLS CUI [1])
schizophrenia management, benefit from a change in antipsychotic medication
Item
have an aspect of schizophrenia management which could potentially benefit from a change in antipsychotic medication
boolean
C0036341 (UMLS CUI [1,1])
C0376636 (UMLS CUI [1,2])
C0814225 (UMLS CUI [2,1])
C0580105 (UMLS CUI [2,2])
C0040615 (UMLS CUI [2,3])
risperidone duration
Item
receive risperidone 4 mg or 6 mg for at least 4 weeks before the start of the study.
boolean
C0073393 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ability to swallow study drug
Item
unable to swallow study drug whole with the aid of water
boolean
C0566355 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
study subject participation status
Item
cannot have received an investigational drug, used an investigational medical device, or participated in a clinical study that altered their medication within 6 months before the first administration of study drug, or have participated in more than 2 investigational drug studies within the past 12 months
boolean
C2348568 (UMLS CUI [1])
other mental disorders, except for tobacco dependance
Item
no other major mental health diagnosis except for tobacco dependance
boolean
C0338607 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
cocaine, heroin
Item
no use of cocaine or heroin within 3 months before the first administration
boolean
C0009170 (UMLS CUI [1])
C0011892 (UMLS CUI [2])
no prior therapy with any antipsychotic, treatment with risperidone, treatment with paliperidone
Item
no history of treatment with any antipsychotic in addition to treatment with risperidone, or treatment with paliperidone, within 30 days before the baseline visit.
boolean
C1514463 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
C0073393 (UMLS CUI [1,3])
C0753678 (UMLS CUI [1,4])

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