ID

14625

Description

CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00272584

Link

https://clinicaltrials.gov/show/NCT00272584

Keywords

  1. 4/24/16 4/24/16 -
Uploaded on

April 24, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Psychosis, Schizophrenia NCT00272584

Eligibility Psychosis, Schizophrenia NCT00272584

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects treated with clozapine for the indication of poor response to other antipsychotic medications.
Description

clozapine

Data type

boolean

Alias
UMLS CUI [1]
C0009079
treatment with clozapine is at a stable dose for at least 12 weeks. dose must be 400 mg/day or more, unless side effects limited increase of dose.
Description

treatment with clozapine stable dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0009079
UMLS CUI [1,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with significant alcohol or substance abuse in the past 3 months.
Description

alcohol or substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
subjects with a previous trial of risperidone augmentation of clozapine
Description

risperidone augmentation

Data type

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C0442805
UMLS CUI [1,3]
C0205156
subjects who are pregnant, breast-feeding, or women of child-bearing potential not using adequate contraception
Description

pregnancy and contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0006147
subjects requiring treatment with anticonvulsants.
Description

anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0003286
subjects with known hypersensitivity or allergy to risperidone.
Description

allergy to risperidone

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0073393
subjects with hematological or other contraindications to continued clozapine treatment.
Description

contraindications to continued clozapine treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0009079

Similar models

Eligibility Psychosis, Schizophrenia NCT00272584

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
clozapine
Item
subjects treated with clozapine for the indication of poor response to other antipsychotic medications.
boolean
C0009079 (UMLS CUI [1])
treatment with clozapine stable dose
Item
treatment with clozapine is at a stable dose for at least 12 weeks. dose must be 400 mg/day or more, unless side effects limited increase of dose.
boolean
C0009079 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
alcohol or substance abuse
Item
subjects with significant alcohol or substance abuse in the past 3 months.
boolean
C0038586 (UMLS CUI [1])
risperidone augmentation
Item
subjects with a previous trial of risperidone augmentation of clozapine
boolean
C0073393 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
pregnancy and contraceptive methods
Item
subjects who are pregnant, breast-feeding, or women of child-bearing potential not using adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
anticonvulsants
Item
subjects requiring treatment with anticonvulsants.
boolean
C0003286 (UMLS CUI [1])
allergy to risperidone
Item
subjects with known hypersensitivity or allergy to risperidone.
boolean
C0020517 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
contraindications to continued clozapine treatment
Item
subjects with hematological or other contraindications to continued clozapine treatment.
boolean
C1301624 (UMLS CUI [1,1])
C0009079 (UMLS CUI [1,2])

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