ID

23111

Description

Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01726335

Link

https://clinicaltrials.gov/show/NCT01726335

Keywords

Versions (1)
  1. 6/24/17 6/24/17 -
Uploaded on

June 24, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01726335

English

Eligibility Schizophrenia NCT01726335

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have schizophrenia diagnosis by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv)
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
be on treatment with oral antipsychotic of first or second generation, for a minimum time of 12 months
Description

Oral antipsychotic therapy

Data type

boolean

Alias
UMLS CUI [1]
C4273790
previous history of bad adhesion to oral antipsychotic treatment in the last 12 months
Description

Oral antipsychotic therapy Effectiveness Bad

Data type

boolean

Alias
UMLS CUI [1,1]
C4273790
UMLS CUI [1,2]
C1280519
UMLS CUI [1,3]
C0205169
total positive and negative syndrome scale score less than or equal to 90, the conceptual disorganization, hallucinatory behavior, suspicion and not usual content of thought must be less than or equal to 4
Description

Positive and negative syndrome scale | PANSS - Conceptual Disorganization | PANSS - Hallucinatory Behavior | PANSS - Suspiciousness | PANSS - Unusual Thought Content

Data type

boolean

Alias
UMLS CUI [1]
C0451383
UMLS CUI [2]
C4086687
UMLS CUI [3]
C4086696
UMLS CUI [4]
C4087067
UMLS CUI [5]
C4086711
be not pregnant as showed on negative pregnancy serum test
Description

Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0430061
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication or known hypersensitivity to risperidone
Description

Medical contraindication Risperidone | Risperidone allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0073393
UMLS CUI [2]
C0570837
previous history of unsatisfactory response to risperidone
Description

Risperidone | Response Unsatisfactory

Data type

boolean

Alias
UMLS CUI [1]
C0073393
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0439856
previous history of refractivity to the other second generation antipsychotics
Description

Antipsychotic Agents | Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C0205269
use of antipsychotic of intramuscular deposit in the last 12 months
Description

Depot antipsychotic agent | Depot Preparations Intramuscular

Data type

boolean

Alias
UMLS CUI [1]
C2585377
UMLS CUI [2,1]
C0086129
UMLS CUI [2,2]
C1556154
other mental disturbances of dsm-iv axis
Description

Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
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Similar models

Eligibility Schizophrenia NCT01726335

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
have schizophrenia diagnosis by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv)
boolean
C0036341 (UMLS CUI [1])
Oral antipsychotic therapy
Item
be on treatment with oral antipsychotic of first or second generation, for a minimum time of 12 months
boolean
C4273790 (UMLS CUI [1])
Oral antipsychotic therapy Effectiveness Bad
Item
previous history of bad adhesion to oral antipsychotic treatment in the last 12 months
boolean
C4273790 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
C0205169 (UMLS CUI [1,3])
Positive and negative syndrome scale | PANSS - Conceptual Disorganization | PANSS - Hallucinatory Behavior | PANSS - Suspiciousness | PANSS - Unusual Thought Content
Item
total positive and negative syndrome scale score less than or equal to 90, the conceptual disorganization, hallucinatory behavior, suspicion and not usual content of thought must be less than or equal to 4
boolean
C0451383 (UMLS CUI [1])
C4086687 (UMLS CUI [2])
C4086696 (UMLS CUI [3])
C4087067 (UMLS CUI [4])
C4086711 (UMLS CUI [5])
Serum pregnancy test negative
Item
be not pregnant as showed on negative pregnancy serum test
boolean
C0430061 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Risperidone | Risperidone allergy
Item
contraindication or known hypersensitivity to risperidone
boolean
C1301624 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
C0570837 (UMLS CUI [2])
Risperidone | Response Unsatisfactory
Item
previous history of unsatisfactory response to risperidone
boolean
C0073393 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0439856 (UMLS CUI [2,2])
Antipsychotic Agents | Unresponsive to Treatment
Item
previous history of refractivity to the other second generation antipsychotics
boolean
C0040615 (UMLS CUI [1])
C0205269 (UMLS CUI [2])
Depot antipsychotic agent | Depot Preparations Intramuscular
Item
use of antipsychotic of intramuscular deposit in the last 12 months
boolean
C2585377 (UMLS CUI [1])
C0086129 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
Mental disorders
Item
other mental disturbances of dsm-iv axis
boolean
C0004936 (UMLS CUI [1])
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