ID

19255

Description

Trial Evaluating Three Fixed Dosages of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00078039

Lien

https://clinicaltrials.gov/show/NCT00078039

Mots-clés

Versions (1)
  1. 15/12/2016 15/12/2016 -
Téléchargé le

15 décembre 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00078039

Anglais

Eligibility Schizophrenia NCT00078039

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
double-blind phase: dsm-iv diagnosis of schizophrenia at least 1 year prior to screening
Description

Schizophrenia disease length

Type de données

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
Description

schizophrenic episode Positive and negative syndrome scale

Type de données

boolean

Alias
UMLS CUI [1,1]
C1396838
UMLS CUI [1,2]
C0451383
agree to voluntary hospitalization for a minimum of 14 days
Description

HOSPITALIZATION VOLUNTARY Duration Agreement

Type de données

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
Description

Questionnaires Self-Administered Completion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C1519231
UMLS CUI [1,3]
C0205197
able to be compliant with self-administration of medication, or have consistent help/support available.
Description

Pharmaceutical Preparations Self-Administered Compliance behavior

Type de données

boolean

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

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

Type de données

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 agree that open-label treatment is in the best interest of the patient.
Description

Open Label Treatment Agreement

Type de données

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
double-blind phase: dsm-iv axis i diagnosis other than schizophrenia
Description

Axis I diagnosis | Schizophrenia

Type de données

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)
Description

Substance Dependence | Nicotine Dependence | Caffeine dependence

Type de données

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
history of tardive dyskinesia or neuroleptic malignant syndrome (nms)
Description

Tardive Dyskinesia | Neuroleptic Malignant Syndrome

Type de données

boolean

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

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

Type de données

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 lack of response (2 adequate trials) to any antipsychotic
Description

Antipsychotic Agents Quantity | Poor response to treatment

Type de données

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 phase: at significant risk for suicidal or violent behavior
Description

Suicidal behavior Risk Significant | Physical aggression Risk Significant | At risk for suicide Significant | At risk for violence Significant

Type de données

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.
Description

Injection of depot antipsychotic agent

Type de données

boolean

Alias
UMLS CUI [1]
C2585377
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Similar models

Eligibility Schizophrenia NCT00078039

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia disease length
Item
double-blind phase: dsm-iv diagnosis of schizophrenia at least 1 year prior to screening
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
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 extension phase: 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 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 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 phase: 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])
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