ID

13880

Description

Brain Myelination Effects of Paliperidone Palmitate Versus Oral Risperidone in First Episode Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01458379

Link

https://clinicaltrials.gov/show/NCT01458379

Keywords

Versions (1)
  1. 3/13/16 3/13/16 -
Uploaded on

March 13, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01458379

English

Eligibility Schizophrenia NCT01458379

1 forms  
Criteria
Description

Criteria

a first episode of a psychotic illness is occurring or did occur within the last 2 years;
Description

psychotic episode

Data type

boolean

Alias
UMLS CUI [1]
C0338614
a diagnosis by dsm-iv of schizophrenia, schizoaffective disorder, depressed type, or schizophreniform disorder; and
Description

dsm-iv schizophrenia schizoaffective disorder Depressive disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0220952
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C0036337
UMLS CUI [1,4]
C0011581
between 18 and 45 years of age.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
exclusion criteria (identical to clinical trial "parent study"):
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
neurological disorder (e.g., epilepsy) or significant head injury;
Description

neurological disorder epilepsy; head injury

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0014544
UMLS CUI [2]
C0018674
significant alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
Description

Substance Use Disorder; psychotic episode

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0338614
mental retardation, i.e. premorbid iq less than 70;
Description

mental retardation

Data type

boolean

Alias
UMLS CUI [1]
C0025362
insufficient acculturation and fluency in the english language to avoid invalidating research measures of thought, language, and speech disorder or of verbal abilities;
Description

english speaking; Speech and language disorder

Data type

boolean

Alias
UMLS CUI [1]
C0376245
UMLS CUI [2]
C0023009
residence likely to be outside of commuting distance of the ucla aftercare research program; or
Description

residence

Data type

boolean

Alias
UMLS CUI [1]
C0237096
patient has shown an inadequate response to an adequate previous trial of oral or long-acting injectable risperidone, paliperidone, or paliperidone palmitate.
Description

treatment resistant risperidone paliperidone paliperidone palmitate

Data type

boolean

Alias
UMLS CUI [1,1]
C4020575
UMLS CUI [1,2]
C0073393
UMLS CUI [1,3]
C0753678
UMLS CUI [1,4]
C2719626
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Similar models

Eligibility Schizophrenia NCT01458379

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
psychotic episode
Item
a first episode of a psychotic illness is occurring or did occur within the last 2 years;
boolean
C0338614 (UMLS CUI [1])
dsm-iv schizophrenia schizoaffective disorder Depressive disorder
Item
a diagnosis by dsm-iv of schizophrenia, schizoaffective disorder, depressed type, or schizophreniform disorder; and
boolean
C0220952 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C0036337 (UMLS CUI [1,3])
C0011581 (UMLS CUI [1,4])
age
Item
between 18 and 45 years of age.
boolean
C0001779 (UMLS CUI [1])
exclusion criteria
Item
exclusion criteria (identical to clinical trial "parent study"):
boolean
C0680251 (UMLS CUI [1])
neurological disorder epilepsy; head injury
Item
neurological disorder (e.g., epilepsy) or significant head injury;
boolean
C0027765 (UMLS CUI [1,1])
C0014544 (UMLS CUI [1,2])
C0018674 (UMLS CUI [2])
Substance Use Disorder; psychotic episode
Item
significant alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
boolean
C0038586 (UMLS CUI [1])
C0338614 (UMLS CUI [2])
mental retardation
Item
mental retardation, i.e. premorbid iq less than 70;
boolean
C0025362 (UMLS CUI [1])
english speaking; Speech and language disorder
Item
insufficient acculturation and fluency in the english language to avoid invalidating research measures of thought, language, and speech disorder or of verbal abilities;
boolean
C0376245 (UMLS CUI [1])
C0023009 (UMLS CUI [2])
residence
Item
residence likely to be outside of commuting distance of the ucla aftercare research program; or
boolean
C0237096 (UMLS CUI [1])
treatment resistant risperidone paliperidone paliperidone palmitate
Item
patient has shown an inadequate response to an adequate previous trial of oral or long-acting injectable risperidone, paliperidone, or paliperidone palmitate.
boolean
C4020575 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
C0753678 (UMLS CUI [1,3])
C2719626 (UMLS CUI [1,4])
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