ID

23041

Description

Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode; ODM derived from: https://clinicaltrials.gov/show/NCT00216671

Link

https://clinicaltrials.gov/show/NCT00216671

Keywords

  1. 6/20/17 6/20/17 -
Uploaded on

June 20, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT00216671

Eligibility Schizophrenia NCT00216671

Inclusion Criteria
Description

Inclusion Criteria

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

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
acute episode of schizophrenia within 2 weeks of study entry
Description

Acute schizophrenic episode

Data type

boolean

Alias
UMLS CUI [1]
C0813173
o subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose
Description

Study Subject untreated | Antipsychotic Agents Oral | Antipsychotic Agents Injectable Active short-term | Zuclopenthixol

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C0086466
UMLS CUI [3,3]
C0205177
UMLS CUI [3,4]
C0443303
UMLS CUI [4]
C0376160
positive and negative syndrome scale (panss) score >=80
Description

Positive and negative syndrome scale

Data type

boolean

Alias
UMLS CUI [1]
C0451383
clinical global impression - severity (cgi-s) score >=5
Description

Clinical Global Impression Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3639708
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
dsm-iv axis i diagnosis other than schizophrenia
Description

Axis I diagnosis | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0036341
known hypersensitivity or lack of response to risperidone
Description

Risperidone allergy | Risperidone Absent response to treatment

Data type

boolean

Alias
UMLS CUI [1]
C0570837
UMLS CUI [2,1]
C0073393
UMLS CUI [2,2]
C0438286
pregnant or nursing females, or those without adequate contraception
Description

Pregnancy | Breast Feeding | Gender Contraceptive methods Inadequate

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0205412
alcohol or drug abuse or dependence diagnosed in the last month prior to entry,
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580

Similar models

Eligibility Schizophrenia NCT00216671

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
diagnosis of schizophrenia by criteria of diagnostic and statistical manual of mental diseases, fourth edition (dsm-iv)
boolean
C0036341 (UMLS CUI [1])
Acute schizophrenic episode
Item
acute episode of schizophrenia within 2 weeks of study entry
boolean
C0813173 (UMLS CUI [1])
Study Subject untreated | Antipsychotic Agents Oral | Antipsychotic Agents Injectable Active short-term | Zuclopenthixol
Item
o subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose
boolean
C0681850 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0040615 (UMLS CUI [3,1])
C0086466 (UMLS CUI [3,2])
C0205177 (UMLS CUI [3,3])
C0443303 (UMLS CUI [3,4])
C0376160 (UMLS CUI [4])
Positive and negative syndrome scale
Item
positive and negative syndrome scale (panss) score >=80
boolean
C0451383 (UMLS CUI [1])
Clinical Global Impression Questionnaire
Item
clinical global impression - severity (cgi-s) score >=5
boolean
C3639708 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Schizophrenia
Item
dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Risperidone allergy | Risperidone Absent response to treatment
Item
known hypersensitivity or lack of response to risperidone
boolean
C0570837 (UMLS CUI [1])
C0073393 (UMLS CUI [2,1])
C0438286 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Gender Contraceptive methods Inadequate
Item
pregnant or nursing females, or those without adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
Substance Use Disorders | Substance Dependence
Item
alcohol or drug abuse or dependence diagnosed in the last month prior to entry,
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])

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