ID

19263

Beschreibung

A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.; ODM derived from: https://clinicaltrials.gov/show/NCT00086320

Link

https://clinicaltrials.gov/show/NCT00086320

Stichworte

Versionen (2)
  1. 16.12.16 16.12.16 -
  2. 16.12.16 16.12.16 -
Hochgeladen am

16. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00086320

Englisch

Eligibility Schizophrenia NCT00086320

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
dsm-iv diagnosis of schizophrenia at least 1 year before screening
Beschreibung

Schizophrenia disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
experiencing an acute schizophrenic episode with a total panss score between 70 and 120
Beschreibung

schizophrenic episode Positive and negative syndrome scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1396838
UMLS CUI [1,2]
C0451383
agree to be hospitalized for a minimum of 14 days at the start of the study
Beschreibung

Hospitalization Duration Agreement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0680240
capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study
Beschreibung

Investigational New Drugs Self-Administered Ability | Investigational New Drugs Administration Assistance Available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1519231
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C1269765
UMLS CUI [2,4]
C0470187
resided at the same address continuously for at least 30 days prior to screening
Beschreibung

residence Address Same Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C1442065
UMLS CUI [1,3]
C0445247
UMLS CUI [1,4]
C0549178
able and willing to fill out self administered questionnaires
Beschreibung

Questionnaires Self-Administered Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C1519231
UMLS CUI [1,3]
C0205197
washout of antiparkinsonian medications, beta-blockers
Beschreibung

Washout Antiparkinson Agents | Washout Adrenergic beta-1 Receptor Antagonists

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0003405
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0304516
antiepileptics, lithium 3 days prior to the start of the run-in phase
Beschreibung

Antiepileptic Agents | Lithium

Datentyp

boolean

Alias
UMLS CUI [1]
C0003299
UMLS CUI [2]
C0023870
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Axis I diagnosis | Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0036341
dsm-iv diagnosis of substance dependence within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
Beschreibung

Substance Dependence | Nicotine Dependence | Caffeine dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
Beschreibung

Gastrointestinal stenosis Pathologic Severe Pre-existing | Gastrointestinal stenosis Iatrogenic Severe Pre-existing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521587
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C0205082
UMLS CUI [1,4]
C2347662
UMLS CUI [2,1]
C0521587
UMLS CUI [2,2]
C0439669
UMLS CUI [2,3]
C0205082
UMLS CUI [2,4]
C2347662
injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
Beschreibung

Injection of depot antipsychotic agent | paliperidone palmitate

Datentyp

boolean

Alias
UMLS CUI [1]
C2585377
UMLS CUI [2]
C2719626
previous history of lack of response to risperidone when acutely psychotic
Beschreibung

Risperidone Psychotic Disorder | Poor response to treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C0033975
UMLS CUI [2]
C1320680
history of neuroleptic malignant syndrome
Beschreibung

Neuroleptic Malignant Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0027849
significant risk of suicidal or violent behavior
Beschreibung

Suicidal behavior Risk Significant | Physical aggression Risk Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1760428
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C0424323
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0750502
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Ähnliche Modelle

Eligibility Schizophrenia NCT00086320

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia disease length
Item
dsm-iv diagnosis of schizophrenia at least 1 year before screening
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
schizophrenic episode Positive and negative syndrome scale
Item
experiencing an acute schizophrenic episode with a total panss score between 70 and 120
boolean
C1396838 (UMLS CUI [1,1])
C0451383 (UMLS CUI [1,2])
Hospitalization Duration Agreement
Item
agree to be hospitalized for a minimum of 14 days at the start of the study
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
Investigational New Drugs Self-Administered Ability | Investigational New Drugs Administration Assistance Available
Item
capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study
boolean
C0013230 (UMLS CUI [1,1])
C1519231 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C1269765 (UMLS CUI [2,3])
C0470187 (UMLS CUI [2,4])
residence Address Same Continuous
Item
resided at the same address continuously for at least 30 days prior to screening
boolean
C0237096 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Questionnaires Self-Administered Completion
Item
able and willing to fill out self administered questionnaires
boolean
C0034394 (UMLS CUI [1,1])
C1519231 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Washout Antiparkinson Agents | Washout Adrenergic beta-1 Receptor Antagonists
Item
washout of antiparkinsonian medications, beta-blockers
boolean
C1710661 (UMLS CUI [1,1])
C0003405 (UMLS CUI [1,2])
C1710661 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
Antiepileptic Agents | Lithium
Item
antiepileptics, lithium 3 days prior to the start of the run-in phase
boolean
C0003299 (UMLS CUI [1])
C0023870 (UMLS CUI [2])
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])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
dsm-iv diagnosis of substance dependence within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Gastrointestinal stenosis Pathologic Severe Pre-existing | Gastrointestinal stenosis Iatrogenic Severe Pre-existing
Item
preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
boolean
C0521587 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C2347662 (UMLS CUI [1,4])
C0521587 (UMLS CUI [2,1])
C0439669 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C2347662 (UMLS CUI [2,4])
Injection of depot antipsychotic agent | paliperidone palmitate
Item
injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
boolean
C2585377 (UMLS CUI [1])
C2719626 (UMLS CUI [2])
Risperidone Psychotic Disorder | Poor response to treatment
Item
previous history of lack of response to risperidone when acutely psychotic
boolean
C0073393 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C1320680 (UMLS CUI [2])
Neuroleptic Malignant Syndrome
Item
history of neuroleptic malignant syndrome
boolean
C0027849 (UMLS CUI [1])
Suicidal behavior Risk Significant | Physical aggression Risk Significant
Item
significant risk of suicidal or violent behavior
boolean
C1760428 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0424323 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
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