ID

19256

Beschreibung

Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00083668

Link

https://clinicaltrials.gov/show/NCT00083668

Stichworte

Versionen (1)
  1. 15.12.16 15.12.16 -
Hochgeladen am

15. Dezember 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Schizophrenia NCT00083668

Englisch

Eligibility Schizophrenia NCT00083668

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
double-blind phase: dsm-iv diagnosis of schizophrenia for at least 1 year
Beschreibung

Schizophrenia disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
experiencing an acute episode, with a total panss score at screening 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 voluntary hospitalization for a minimum of 14 days
Beschreibung

HOSPITALIZATION VOLUNTARY Duration Agreement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0745044
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0680240
willing and able 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
must be able to be compliant with self-administration of medication, or have consistent help/support available.
Beschreibung

Pharmaceutical Preparations Self-Administered Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1519231
UMLS CUI [1,3]
C1321605
open-label phase: have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy
Beschreibung

Therapeutic procedure Double-Blind Method Complete | Therapeutic procedure Discontinued Lack of Efficacy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013072
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0235828
patient and investigator must agree that open-label treatment is in the best interest of the patient.
Beschreibung

Open Label Treatment Agreement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3640652
UMLS CUI [1,2]
C0680240
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
double-blind phase: 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 evaluation (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
history of tardive dyskinesia or neuroleptic malignant syndrome (nms)
Beschreibung

Tardive Dyskinesia | Neuroleptic Malignant Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2]
C0027849
history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521587
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C2347662
UMLS CUI [1,4]
C0205082
UMLS CUI [2,1]
C0521587
UMLS CUI [2,2]
C0439669
UMLS CUI [2,3]
C2347662
UMLS CUI [2,4]
C0205082
previous history of a lack of response (2 adequate trials) to any antipsychotic
Beschreibung

Antipsychotic Agents Quantity | Poor response to treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1320680
significant risk of suicidal or violent behavior. open-label extension: patients believed by the investigator to be at significant risk for suicidal or violent behavior
Beschreibung

Suicidal behavior Risk Significant | Physical aggression Risk Significant | At risk for suicide Significant | At risk for violence 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
UMLS CUI [3,1]
C0563664
UMLS CUI [3,2]
C0750502
UMLS CUI [4,1]
C0231418
UMLS CUI [4,2]
C0750502
received an injection of a depot antipsychotic since entry into the preceding double-blind phase.
Beschreibung

Injection of depot antipsychotic agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2585377
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Schizophrenia NCT00083668

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia disease length
Item
double-blind phase: dsm-iv diagnosis of schizophrenia for at least 1 year
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
schizophrenic episode Positive and negative syndrome scale
Item
experiencing an acute episode, with a total panss score at screening between 70 and 120
boolean
C1396838 (UMLS CUI [1,1])
C0451383 (UMLS CUI [1,2])
HOSPITALIZATION VOLUNTARY Duration Agreement
Item
agree to voluntary hospitalization for a minimum of 14 days
boolean
C0745044 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
Questionnaires Self-Administered Completion
Item
willing and able to fill out self-administered questionnaires
boolean
C0034394 (UMLS CUI [1,1])
C1519231 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Pharmaceutical Preparations Self-Administered Compliance behavior
Item
must be able to be compliant with self-administration of medication, or have consistent help/support available.
boolean
C0013227 (UMLS CUI [1,1])
C1519231 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Therapeutic procedure Double-Blind Method Complete | Therapeutic procedure Discontinued Lack of Efficacy
Item
open-label phase: have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy
boolean
C0087111 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0235828 (UMLS CUI [2,3])
Open Label Treatment Agreement
Item
patient and investigator must agree that open-label treatment is in the best interest of the patient.
boolean
C3640652 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Schizophrenia
Item
double-blind phase: 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 evaluation (nicotine and caffeine dependence are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Tardive Dyskinesia | Neuroleptic Malignant Syndrome
Item
history of tardive dyskinesia or neuroleptic malignant syndrome (nms)
boolean
C0686347 (UMLS CUI [1])
C0027849 (UMLS CUI [2])
Gastrointestinal stenosis Pathologic Pre-existing Severe | Gastrointestinal stenosis Iatrogenic Pre-existing Severe
Item
history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
boolean
C0521587 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0521587 (UMLS CUI [2,1])
C0439669 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
Antipsychotic Agents Quantity | Poor response to treatment
Item
previous history of a lack of response (2 adequate trials) to any antipsychotic
boolean
C0040615 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [2])
Suicidal behavior Risk Significant | Physical aggression Risk Significant | At risk for suicide Significant | At risk for violence Significant
Item
significant risk of suicidal or violent behavior. open-label extension: patients believed by the investigator to be at significant risk for 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])
C0563664 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0231418 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
Injection of depot antipsychotic agent
Item
received an injection of a depot antipsychotic since entry into the preceding double-blind phase.
boolean
C2585377 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video