ID

19249

Description

Trial Evaluating the Efficacy and Safety of 2 Fixed Doses of Paliperidone Extended-Release (ER) Tablets in the Treatment of Adult Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00077714

Link

https://clinicaltrials.gov/show/NCT00077714

Keywords

Versions (2)
  1. 12/15/16 12/15/16 -
  2. 12/15/16 12/15/16 -
Uploaded on

December 15, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Schizophrenia NCT00077714

English

Eligibility Schizophrenia NCT00077714

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Schizophrenia disease length

Data type

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1396838
UMLS CUI [1,2]
C0451383
agree to voluntary hospitalization for a minimum of 14 days. open-label phase: must have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy.
Description

HOSPITALIZATION VOLUNTARY Duration Agreement | Therapeutic procedure Double-Blind Method Complete | Therapeutic procedure Discontinued Lack of Efficacy

Data type

boolean

Alias
UMLS CUI [1,1]
C0745044
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0680240
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0013072
UMLS CUI [2,3]
C0205197
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0235828
Exclusion Criteria
Description

Exclusion Criteria

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

Axis I diagnosis | Schizophrenia

Data type

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

Data type

boolean

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

Neuroleptic Malignant Syndrome

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0521587
UMLS CUI [1,2]
C3816499
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 to risperidone when acutely psychotic
Description

Risperidone Psychotic Disorder | Poor response to treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C0033975
UMLS CUI [2]
C1320680
significant risk of suicidal or violent behavior.
Description

Suicidal behavior Risk Significant | Physical aggression Risk Significant

Data type

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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Similar models

Eligibility Schizophrenia NCT00077714

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 | Therapeutic procedure Double-Blind Method Complete | Therapeutic procedure Discontinued Lack of Efficacy
Item
agree to voluntary hospitalization for a minimum of 14 days. open-label phase: must 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
C0745044 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0013072 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0235828 (UMLS CUI [3,3])
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 evaluation (nicotine and caffeine dependence are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Neuroleptic Malignant Syndrome
Item
history of neuroleptic malignant syndrome (nms)
boolean
C0027849 (UMLS CUI [1])
Gastrointestinal stenosis Pathogenic 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])
C3816499 (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])
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])
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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