ID

16897

Description

Clozapine and Olanzapine Treatment of Aggression; ODM derived from: https://clinicaltrials.gov/show/NCT01123408

Link

https://clinicaltrials.gov/show/NCT01123408

Keywords

Versions (1)
  1. 8/13/16 8/13/16 -
Uploaded on

August 13, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01123408

English

Eligibility Schizophrenia NCT01123408

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 18 to 60 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of schizophrenia or schizoaffective disorder.
Description

Schizophrenia or schizoaffective disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
aggression: one episode of physical assault directed at another person in the hospital and persistence of violence/hostility for two weeks, as evidenced by the presence of some other physical, verbal or property assault or hostility, which would result in a score of 4 or more on the positive and negative syndrome scale (panss) hostility item.
Description

Aggression and PANSS

Data type

boolean

Alias
UMLS CUI [1]
C0001807
UMLS CUI [2]
C0451383
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who were hospitalized for more than a year
Description

Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0019993
patients who had a history of nonresponse to clozapine, olanzapine or haloperidol (defined as a lack of improvement despite a contiguous adequate trial of medication)
Description

Nonresponse to clozapine, olanzapine or haloperidol

Data type

boolean

Alias
UMLS CUI [1,1]
C3845351
UMLS CUI [1,2]
C0009079
UMLS CUI [2,1]
C3845351
UMLS CUI [2,2]
C0171023
UMLS CUI [3,1]
C3845351
UMLS CUI [3,2]
C0018546
patients who had a history of clozapine, olanzapine, or haloperidol intolerance
Description

Intolerance to clozapine, olanzapine, or haloperidol

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0009079
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0171023
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0018546
patients who had medical conditions that would be adversely affected by any of these three medications.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients who received a depot antipsychotic within 30 days before randomization.
Description

Depot antipsychotic medication

Data type

boolean

Alias
UMLS CUI [1]
C2585377
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Similar models

Eligibility Schizophrenia NCT01123408

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 18 to 60 years.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia or schizoaffective disorder
Item
diagnosis of schizophrenia or schizoaffective disorder.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Aggression and PANSS
Item
aggression: one episode of physical assault directed at another person in the hospital and persistence of violence/hostility for two weeks, as evidenced by the presence of some other physical, verbal or property assault or hostility, which would result in a score of 4 or more on the positive and negative syndrome scale (panss) hostility item.
boolean
C0001807 (UMLS CUI [1])
C0451383 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hospitalization
Item
patients who were hospitalized for more than a year
boolean
C0019993 (UMLS CUI [1])
Nonresponse to clozapine, olanzapine or haloperidol
Item
patients who had a history of nonresponse to clozapine, olanzapine or haloperidol (defined as a lack of improvement despite a contiguous adequate trial of medication)
boolean
C3845351 (UMLS CUI [1,1])
C0009079 (UMLS CUI [1,2])
C3845351 (UMLS CUI [2,1])
C0171023 (UMLS CUI [2,2])
C3845351 (UMLS CUI [3,1])
C0018546 (UMLS CUI [3,2])
Intolerance to clozapine, olanzapine, or haloperidol
Item
patients who had a history of clozapine, olanzapine, or haloperidol intolerance
boolean
C1744706 (UMLS CUI [1,1])
C0009079 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0171023 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0018546 (UMLS CUI [3,2])
Comorbidity
Item
patients who had medical conditions that would be adversely affected by any of these three medications.
boolean
C0009488 (UMLS CUI [1])
Depot antipsychotic medication
Item
patients who received a depot antipsychotic within 30 days before randomization.
boolean
C2585377 (UMLS CUI [1])
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