ID

25308

Beschreibung

The Paliperidone ER Observational Study of Economic, Functional, and Clinical Outcomes in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00488891

Link

https://clinicaltrials.gov/show/NCT00488891

Stichworte

Versionen (1)
  1. 31.08.17 31.08.17 -
Hochgeladen am

31. August 2017

DOI

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Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00488891

Englisch

Eligibility Schizophrenia NCT00488891

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have a clinical diagnosis of schizophrenia for at least 1 year prior to screening
Beschreibung

Schizophrenia disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
had been receiving treatment with antipsychotics, but is judged to be a candidate for changing antipsychotic on the basis of either persistent symptoms or continuing side effects
Beschreibung

Antipsychotic Agents | Antipsychotic Agents Change Expected | Symptoms persistent | Adverse effects continuing

Datentyp

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C1517001
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0205322
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C0549178
treating physician has determined, before the patient enters the study, that starting paliperidone extended release (er) or another of at least two possible atypical antipsychotics (aaps) is an appropriate treatment for the patient
Beschreibung

Paliperidone ER | Atypical antipsychotic Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0753678
UMLS CUI [1,2]
C1707968
UMLS CUI [2,1]
C1276996
UMLS CUI [2,2]
C1265611
likely to be managed as outpatient
Beschreibung

Outpatient Probably

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0750492
must have signed the informed consent form for dna pharmacogenomic
Beschreibung

Informed Consent Pharmacogenomic Analysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C4084975
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
have mental retardation, dementia, bipolar, schizoaffective disorder, schizophreniform disease, other diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) psychiatric disorders or deteriorating neurological illnesses as determined by clinical evaluation
Beschreibung

Mental Retardation | Dementia | Bipolar Disorder | Schizoaffective Disorder | Schizophreniform Disorders | Mental disorders | Nervous system disorder Worsening

Datentyp

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0005586
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0036358
UMLS CUI [6]
C0004936
UMLS CUI [7,1]
C0027765
UMLS CUI [7,2]
C0332271
established treatment-resistant schizophrenia, defined as those who have had treatment failures with adequate trials of two second generation atypicals, previous treatment with clozapine, or 4 or more hospitalizations in the last 12 months
Beschreibung

Treatment-resistant schizophrenia | Atypical antipsychotic Quantity failed | Clozapine | Hospitalization Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C3544321
UMLS CUI [2,1]
C1276996
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C0009079
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C1265611
history of recent violence or at immediate risk of suicide, or harming self or others, or of causing damage to property, in the judgment of the investigator
Beschreibung

Violence | At risk for suicide Immediate | At risk Self-harming behaviors | At risk of harming others | At risk Causing Damage Property

Datentyp

boolean

Alias
UMLS CUI [1]
C0042693
UMLS CUI [2,1]
C0563664
UMLS CUI [2,2]
C0205253
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C3280486
UMLS CUI [4]
C1271966
UMLS CUI [5,1]
C1444641
UMLS CUI [5,2]
C0678227
UMLS CUI [5,3]
C1883709
UMLS CUI [5,4]
C0871161
patients who are unable to swallow the medication whole
Beschreibung

Lacking Able to swallow Oral medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
history or circumstances that may increase the risk of occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the qtc interval, including bradycardia, hypokalemia or hypomagnesemia, concomitant use of drugs that prolong the qtc interval, or presence of congenital long qt syndrome
Beschreibung

Medical History At risk Torsades de Pointes | Medical History At risk Sudden death | Circumstances At risk Torsades de Pointes | Circumstances At risk Sudden death | Prolonged QTc interval Due to Drug use | Bradycardia | Hypokalemia | Hypomagnesemia | Congenital long QT syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0040479
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0011071
UMLS CUI [3,1]
C0680082
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0040479
UMLS CUI [4,1]
C0680082
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0011071
UMLS CUI [5,1]
C1560305
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0242510
UMLS CUI [6]
C0428977
UMLS CUI [7]
C0020621
UMLS CUI [8]
C0151723
UMLS CUI [9]
C1141890
pregnant (as confirmed by urine pregnancy test performed at baseline), planning to become pregnant, or breast-feeding.
Beschreibung

Pregnancy Urine pregnancy test | Pregnancy, Planned | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430056
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
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Ähnliche Modelle

Eligibility Schizophrenia NCT00488891

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia disease length
Item
must have a clinical diagnosis of schizophrenia for at least 1 year prior to screening
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Antipsychotic Agents | Antipsychotic Agents Change Expected | Symptoms persistent | Adverse effects continuing
Item
had been receiving treatment with antipsychotics, but is judged to be a candidate for changing antipsychotic on the basis of either persistent symptoms or continuing side effects
boolean
C0040615 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
C1457887 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C0879626 (UMLS CUI [4,1])
C0549178 (UMLS CUI [4,2])
Paliperidone ER | Atypical antipsychotic Quantity
Item
treating physician has determined, before the patient enters the study, that starting paliperidone extended release (er) or another of at least two possible atypical antipsychotics (aaps) is an appropriate treatment for the patient
boolean
C0753678 (UMLS CUI [1,1])
C1707968 (UMLS CUI [1,2])
C1276996 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Outpatient Probably
Item
likely to be managed as outpatient
boolean
C0029921 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
Informed Consent Pharmacogenomic Analysis
Item
must have signed the informed consent form for dna pharmacogenomic
boolean
C0021430 (UMLS CUI [1,1])
C4084975 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Mental Retardation | Dementia | Bipolar Disorder | Schizoaffective Disorder | Schizophreniform Disorders | Mental disorders | Nervous system disorder Worsening
Item
have mental retardation, dementia, bipolar, schizoaffective disorder, schizophreniform disease, other diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) psychiatric disorders or deteriorating neurological illnesses as determined by clinical evaluation
boolean
C0025362 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0036358 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0027765 (UMLS CUI [7,1])
C0332271 (UMLS CUI [7,2])
Treatment-resistant schizophrenia | Atypical antipsychotic Quantity failed | Clozapine | Hospitalization Quantity
Item
established treatment-resistant schizophrenia, defined as those who have had treatment failures with adequate trials of two second generation atypicals, previous treatment with clozapine, or 4 or more hospitalizations in the last 12 months
boolean
C3544321 (UMLS CUI [1])
C1276996 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0009079 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Violence | At risk for suicide Immediate | At risk Self-harming behaviors | At risk of harming others | At risk Causing Damage Property
Item
history of recent violence or at immediate risk of suicide, or harming self or others, or of causing damage to property, in the judgment of the investigator
boolean
C0042693 (UMLS CUI [1])
C0563664 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C1444641 (UMLS CUI [3,1])
C3280486 (UMLS CUI [3,2])
C1271966 (UMLS CUI [4])
C1444641 (UMLS CUI [5,1])
C0678227 (UMLS CUI [5,2])
C1883709 (UMLS CUI [5,3])
C0871161 (UMLS CUI [5,4])
Lacking Able to swallow Oral medication
Item
patients who are unable to swallow the medication whole
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
Medical History At risk Torsades de Pointes | Medical History At risk Sudden death | Circumstances At risk Torsades de Pointes | Circumstances At risk Sudden death | Prolonged QTc interval Due to Drug use | Bradycardia | Hypokalemia | Hypomagnesemia | Congenital long QT syndrome
Item
history or circumstances that may increase the risk of occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the qtc interval, including bradycardia, hypokalemia or hypomagnesemia, concomitant use of drugs that prolong the qtc interval, or presence of congenital long qt syndrome
boolean
C0262926 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0011071 (UMLS CUI [2,3])
C0680082 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0040479 (UMLS CUI [3,3])
C0680082 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0011071 (UMLS CUI [4,3])
C1560305 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0242510 (UMLS CUI [5,3])
C0428977 (UMLS CUI [6])
C0020621 (UMLS CUI [7])
C0151723 (UMLS CUI [8])
C1141890 (UMLS CUI [9])
Pregnancy Urine pregnancy test | Pregnancy, Planned | Breast Feeding
Item
pregnant (as confirmed by urine pregnancy test performed at baseline), planning to become pregnant, or breast-feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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