ID

12808

Beschrijving

A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01051531

Link

https://clinicaltrials.gov/show/NCT01051531

Trefwoorden

Versies (1)
  1. 21-12-15 21-12-15 -
Geüploaded op

21 december 2015

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01051531

Engels

Eligibility Schizophrenia NCT01051531

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent to participate in the study obtained
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
signed informed consent to participate in the optional pharmacogenomic component of the study obtained (refusal to give consent for the pharmacogenomic component of the study does not exclude a patient from participation in the clinical study)
Beschrijving

informed consent; Pharmacogenomics

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1138555
confirmation of diagnosis of schizophrenia according to the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) within 5 years prior to screening
Beschrijving

schizophrenia; DSM-IV

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0220952
patient is willing and able to fill out self-administered questionnaires during the study
Beschrijving

compliance

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
confirmation that patient has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time before enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
Beschrijving

dose Antipsychotic Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0040615
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient's psychiatric diagnosis is due to the direct pharmacological effects of a drug of abuse substance or medication, or is due to a general medical condition (eg, clinically notable hypothyroidism)
Beschrijving

diagnosis Psychiatric; Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0205487
UMLS CUI [2]
C0038586
the patient is treatment resistant in the judgment of the investigator
Beschrijving

Treatment-Resistant

Datatype

boolean

Alias
UMLS CUI [1]
C4020575
the patient meets the dsm-iv definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry
Beschrijving

dsm-iv; substance dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0220952
UMLS CUI [2]
C0038580
the patient has a previously defined hypersensitivity (anaphylaxis-type reaction) to risperidone or paliperidone or excipients
Beschrijving

hypersensitivity risperidone

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0073393
the patient has received treatment with a long-acting injectable antipsychotic within 3 injection cycles prior to baseline, received clozapine within 3 months prior to screening, received treatment with other investigational agents within 30 days of the screening visit, has participated in more than one investigational drug study in the past 12 months, or has planned use of other investigational drugs during the time frame of the study
Beschrijving

Antipsychotic Agents Injectables; clozapine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0086466
UMLS CUI [2]
C0009079
history or current symptoms of tardive dyskinesia, history of neuroleptic malignant syndrome, or evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months
Beschrijving

comorbidity; cardiovascular disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0007222
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Similar models

Eligibility Schizophrenia NCT01051531

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
signed informed consent to participate in the study obtained
boolean
C0021430 (UMLS CUI [1])
informed consent; Pharmacogenomics
Item
signed informed consent to participate in the optional pharmacogenomic component of the study obtained (refusal to give consent for the pharmacogenomic component of the study does not exclude a patient from participation in the clinical study)
boolean
C0021430 (UMLS CUI [1])
C1138555 (UMLS CUI [2])
schizophrenia; DSM-IV
Item
confirmation of diagnosis of schizophrenia according to the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) within 5 years prior to screening
boolean
C0036341 (UMLS CUI [1])
C0220952 (UMLS CUI [2])
compliance
Item
patient is willing and able to fill out self-administered questionnaires during the study
boolean
C1321605 (UMLS CUI [1])
dose Antipsychotic Agents
Item
confirmation that patient has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time before enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
boolean
C3174092 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
diagnosis Psychiatric; Substance Use Disorders
Item
the patient's psychiatric diagnosis is due to the direct pharmacological effects of a drug of abuse substance or medication, or is due to a general medical condition (eg, clinically notable hypothyroidism)
boolean
C0011900 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
Treatment-Resistant
Item
the patient is treatment resistant in the judgment of the investigator
boolean
C4020575 (UMLS CUI [1])
dsm-iv; substance dependence
Item
the patient meets the dsm-iv definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry
boolean
C0220952 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
hypersensitivity risperidone
Item
the patient has a previously defined hypersensitivity (anaphylaxis-type reaction) to risperidone or paliperidone or excipients
boolean
C0020517 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
Antipsychotic Agents Injectables; clozapine
Item
the patient has received treatment with a long-acting injectable antipsychotic within 3 injection cycles prior to baseline, received clozapine within 3 months prior to screening, received treatment with other investigational agents within 30 days of the screening visit, has participated in more than one investigational drug study in the past 12 months, or has planned use of other investigational drugs during the time frame of the study
boolean
C0040615 (UMLS CUI [1,1])
C0086466 (UMLS CUI [1,2])
C0009079 (UMLS CUI [2])
comorbidity; cardiovascular disease
Item
history or current symptoms of tardive dyskinesia, history of neuroleptic malignant syndrome, or evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months
boolean
C0009488 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
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