ID

37168

Description

Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT01584466

Link

https://clinicaltrials.gov/show/NCT01584466

Keywords

Versions (1)
  1. 7/5/19 7/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01584466

English

Eligibility Schizophrenia NCT01584466

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
be between ages 18 and 64
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
either gender
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
any race
Description

Racial group Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C1552551
meet dsm-iv-tr criteria for schizophrenia or schizoaffective disorder.
Description

Schizophrenia | Schizoaffective Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
alcohol and/or cannabis use defined as a dsm-iv diagnosis abuse, dependence or regular use defined as 3 times per week during the past year
Description

Alcohol consumption | Cannabis use | Alcohol abuse | Cannabis Abuse | Alcoholic Intoxication, Chronic | Cannabis Dependence | Alcohol consumption Regular times/week | Cannabis use Regular times/week

Data type

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C3160814
UMLS CUI [3]
C0085762
UMLS CUI [4]
C0006868
UMLS CUI [5]
C0001973
UMLS CUI [6]
C0006870
UMLS CUI [7,1]
C0001948
UMLS CUI [7,2]
C0205272
UMLS CUI [7,3]
C0456698
UMLS CUI [8,1]
C3160814
UMLS CUI [8,2]
C0205272
UMLS CUI [8,3]
C0456698
agree to take or use birth control during the study.
Description

Contraceptive methods Agreement

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0680240
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous lack of response or serious adverse event to risperidone or paliperidone.
Description

Risperidone Response Lacking | Risperidone Serious Adverse Event | Paliperidone Response Lacking | Paliperidone Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0073393
UMLS CUI [2,2]
C1519255
UMLS CUI [3,1]
C0753678
UMLS CUI [3,2]
C1704632
UMLS CUI [3,3]
C0332268
UMLS CUI [4,1]
C0753678
UMLS CUI [4,2]
C1519255
currently on a long acting injectable antipsychotic.
Description

Antipsychotic Agent Injectable Long-term Active

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0086466
UMLS CUI [1,3]
C0443252
UMLS CUI [1,4]
C0205177
a score of less than 10 on the evaluation to sign consent (esc).
Description

Evaluation Signing consent Score | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0742766
UMLS CUI [1,3]
C0449820
UMLS CUI [2]
C3846158
medical illnesses, which may compromise safe study participation.
Description

Illness Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
pregnant and lactating females.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
qtc interval > 450 milliseconds males or > 470 milliseconds in females
Description

Prolonged QTc interval | Gender

Data type

boolean

Alias
UMLS CUI [1]
C1560305
UMLS CUI [2]
C0079399
currently on acamprosate, naltrexone and disulfiram.
Description

acamprosate | Naltrexone | Disulfiram

Data type

boolean

Alias
UMLS CUI [1]
C0284941
UMLS CUI [2]
C0027360
UMLS CUI [3]
C0012772
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Similar models

Eligibility Schizophrenia NCT01584466

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
be between ages 18 and 64
boolean
C0001779 (UMLS CUI [1])
Gender
Item
either gender
boolean
C0079399 (UMLS CUI [1])
Racial group Any
Item
any race
boolean
C0034510 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Schizophrenia | Schizoaffective Disorder
Item
meet dsm-iv-tr criteria for schizophrenia or schizoaffective disorder.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Alcohol consumption | Cannabis use | Alcohol abuse | Cannabis Abuse | Alcoholic Intoxication, Chronic | Cannabis Dependence | Alcohol consumption Regular times/week | Cannabis use Regular times/week
Item
alcohol and/or cannabis use defined as a dsm-iv diagnosis abuse, dependence or regular use defined as 3 times per week during the past year
boolean
C0001948 (UMLS CUI [1])
C3160814 (UMLS CUI [2])
C0085762 (UMLS CUI [3])
C0006868 (UMLS CUI [4])
C0001973 (UMLS CUI [5])
C0006870 (UMLS CUI [6])
C0001948 (UMLS CUI [7,1])
C0205272 (UMLS CUI [7,2])
C0456698 (UMLS CUI [7,3])
C3160814 (UMLS CUI [8,1])
C0205272 (UMLS CUI [8,2])
C0456698 (UMLS CUI [8,3])
Contraceptive methods Agreement
Item
agree to take or use birth control during the study.
boolean
C0700589 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Risperidone Response Lacking | Risperidone Serious Adverse Event | Paliperidone Response Lacking | Paliperidone Serious Adverse Event
Item
previous lack of response or serious adverse event to risperidone or paliperidone.
boolean
C0073393 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0073393 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0753678 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C0753678 (UMLS CUI [4,1])
C1519255 (UMLS CUI [4,2])
Antipsychotic Agent Injectable Long-term Active
Item
currently on a long acting injectable antipsychotic.
boolean
C0040615 (UMLS CUI [1,1])
C0086466 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C0205177 (UMLS CUI [1,4])
Evaluation Signing consent Score | Other Coding
Item
a score of less than 10 on the evaluation to sign consent (esc).
boolean
C1261322 (UMLS CUI [1,1])
C0742766 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Illness Study Subject Participation Status At risk
Item
medical illnesses, which may compromise safe study participation.
boolean
C0221423 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant and lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prolonged QTc interval | Gender
Item
qtc interval > 450 milliseconds males or > 470 milliseconds in females
boolean
C1560305 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
acamprosate | Naltrexone | Disulfiram
Item
currently on acamprosate, naltrexone and disulfiram.
boolean
C0284941 (UMLS CUI [1])
C0027360 (UMLS CUI [2])
C0012772 (UMLS CUI [3])
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