ID

12454

Beschrijving

European Long-acting Antipsychotics in Schizophrenia Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02146547

Link

https://clinicaltrials.gov/show/NCT02146547

Trefwoorden

  1. 20-11-15 20-11-15 -
Geüploaded op

20 november 2015

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Schizophrenia DRKS00007568 NCT02146547

Eligibility Schizophrenia NCT02146547

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of schizophrenia as defined by dsm-iv-r (diagnostic and statistical manual) as determined by the m.i.n.i.plus
Beschrijving

Diagnosis of schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
2. age 18 or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. the first psychosis occurred at least one year and no more than 7 years ago.
Beschrijving

First psychosis

Datatype

boolean

Alias
UMLS CUI [1]
C3887134
4. if patients are using an antipsychotic drug, a medication switch is currently under consideration.
Beschrijving

Antipsychotic drug

Datatype

boolean

Alias
UMLS CUI [1]
C0040615
5. capable of providing written informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. intolerance / hypersensitivity to one of the drugs (including active substances, metabolites and excipients) in this study including oral paliperidone and aripiprazole and/or hypersensitivity to risperidone.
Beschrijving

Hypersensitivity to drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0753678
UMLS CUI [2,1]
C0073393
UMLS CUI [2,2]
C0020517
2. pregnancy or lactation.
Beschrijving

Pregnancy or lactation

Datatype

boolean

Alias
UMLS CUI [1]
C2986850
3. patients who are currently using clozapine.
Beschrijving

Clozapine

Datatype

boolean

Alias
UMLS CUI [1]
C0009079
4. patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate.
Beschrijving

patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate.

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
5. patients with a documented history of intolerance to any of the study medications and/or a documented history of non-response to a treatment with one of the study drugs of at least 6 weeks within the registered dose range.
Beschrijving

Medication intolerance

Datatype

boolean

Alias
UMLS CUI [1]
C2321306
6. forensic patients.
Beschrijving

Forensic patients

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016558
UMLS CUI [1,2]
C0030705
7. patients who have been treated with an investigational drug within 30 days prior to screening.
Beschrijving

Investigational drug

Datatype

boolean

8. simultaneous participation in another intervention study (neither medication or psychosocial intervention).
Beschrijving

Simultaneous participation in another intervention study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Schizophrenia NCT02146547

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis of schizophrenia
Item
1. diagnosis of schizophrenia as defined by dsm-iv-r (diagnostic and statistical manual) as determined by the m.i.n.i.plus
boolean
C0036341 (UMLS CUI [1])
Age
Item
2. age 18 or older.
boolean
C0001779 (UMLS CUI [1])
First psychosis
Item
3. the first psychosis occurred at least one year and no more than 7 years ago.
boolean
C3887134 (UMLS CUI [1])
Antipsychotic drug
Item
4. if patients are using an antipsychotic drug, a medication switch is currently under consideration.
boolean
C0040615 (UMLS CUI [1])
Informed consent
Item
5. capable of providing written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity to drugs
Item
1. intolerance / hypersensitivity to one of the drugs (including active substances, metabolites and excipients) in this study including oral paliperidone and aripiprazole and/or hypersensitivity to risperidone.
boolean
C0020517 (UMLS CUI [1,1])
C0753678 (UMLS CUI [1,2])
C0073393 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
Pregnancy or lactation
Item
2. pregnancy or lactation.
boolean
C2986850 (UMLS CUI [1])
Clozapine
Item
3. patients who are currently using clozapine.
boolean
C0009079 (UMLS CUI [1])
patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate.
Item
4. patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate.
boolean
C1321605 (UMLS CUI [1])
Medication intolerance
Item
5. patients with a documented history of intolerance to any of the study medications and/or a documented history of non-response to a treatment with one of the study drugs of at least 6 weeks within the registered dose range.
boolean
C2321306 (UMLS CUI [1])
Forensic patients
Item
6. forensic patients.
boolean
C0016558 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Investigational drug
Item
7. patients who have been treated with an investigational drug within 30 days prior to screening.
boolean
Simultaneous participation in another intervention study
Item
8. simultaneous participation in another intervention study (neither medication or psychosocial intervention).
boolean
C2348568 (UMLS CUI [1])

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