ID

39935

Description

A RCT Study in Schizophrenia Relapse Prevention; ODM derived from: https://clinicaltrials.gov/show/NCT01885923

Link

https://clinicaltrials.gov/show/NCT01885923

Keywords

Versions (4)
  1. 1/19/19 1/19/19 -
  2. 2/11/20 2/11/20 - Christian Arras
  3. 3/4/20 3/4/20 - Christian Arras
  4. 3/5/20 3/5/20 - Sarah Riepenhausen
Copyright Holder

Prague Psychiatric Center

Uploaded on

March 5, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Relapse Schizophrenia NCT01885923

English

Eligibility Relapse Schizophrenia NCT01885923

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women, ages 18 to 60 years, inclusive.
Description

Gender, Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
a diagnosis of schizophrenia or schizoaffective disorder according to icd-10 classification.
Description

Diagnosis schizophrenia or schizoaffective disorder, ICD-10

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C1137110
having at least two psychiatric hospitalization for psychosis before the study enrollment.
Description

count of entities of psychiatric hospitalization for psychosis before study

Data type

boolean

Alias
UMLS CUI [1,1]
C0748061
UMLS CUI [1,2]
C0033975
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0008976
UMLS CUI [1,5]
C0449788
severity (cgi-s) ≤ 3 at study visit 1.
Description

Severity, CGI-S

Data type

boolean

Alias
UMLS CUI [1]
C3639887
all patients must be on stable doses of antipsychotic medication during the study entry.
Description

stable doses of Antipsychotic agents during Study entry

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0678766
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
organic mental disorder
Description

Organic mental disorder

Data type

boolean

Alias
UMLS CUI [1]
C0029221
mental disorder due to psychoactive substance use or mental retardation.
Description

Mental disorder, psychoactive substance, mental retardation

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0682880
UMLS CUI [2]
C0025362
participation in another relapse prevention program.
Description

participation, relapse prevention

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0679867
hayward compliance rating scale score < 2 at visit 1.
Description

compliance behavior, rating scale

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0681889
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Similar models

Eligibility Relapse Schizophrenia NCT01885923

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender, Age
Item
men and women, ages 18 to 60 years, inclusive.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diagnosis schizophrenia or schizoaffective disorder, ICD-10
Item
a diagnosis of schizophrenia or schizoaffective disorder according to icd-10 classification.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C1137110 (UMLS CUI [3])
count of entities of psychiatric hospitalization for psychosis before study
Item
having at least two psychiatric hospitalization for psychosis before the study enrollment.
boolean
C0748061 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0449788 (UMLS CUI [1,5])
Severity, CGI-S
Item
severity (cgi-s) ≤ 3 at study visit 1.
boolean
C3639887 (UMLS CUI [1])
stable doses of Antipsychotic agents during Study entry
Item
all patients must be on stable doses of antipsychotic medication during the study entry.
boolean
C0040615 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Organic mental disorder
Item
organic mental disorder
boolean
C0029221 (UMLS CUI [1])
Mental disorder, psychoactive substance, mental retardation
Item
mental disorder due to psychoactive substance use or mental retardation.
boolean
C0004936 (UMLS CUI [1,1])
C0682880 (UMLS CUI [1,2])
C0025362 (UMLS CUI [2])
participation, relapse prevention
Item
participation in another relapse prevention program.
boolean
C0679823 (UMLS CUI [1,1])
C0679867 (UMLS CUI [1,2])
compliance behavior, rating scale
Item
hayward compliance rating scale score < 2 at visit 1.
boolean
C1321605 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
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