ID

19246

Beskrivning

Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00074477

Länk

https://clinicaltrials.gov/show/NCT00074477

Nyckelord

Versioner (1)
  1. 2016-12-15 2016-12-15 -
Uppladdad den

15 december 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00074477

Engelsk

Eligibility Schizophrenia NCT00074477

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with schizophrenia
Beskrivning

Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
for at least 1 year before screening
Beskrivning

disease length

Datatyp

boolean

Alias
UMLS CUI [1]
C0872146
meet panss score criteria
Beskrivning

Positive and negative syndrome scale criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
must agree to hospitalization for a minimum of 14 days
Beskrivning

Hospitalization Duration agreement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0680240
body mass index (bmi) <35.0 kilogram (kg)/meter (m)2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are involuntarily committed as in-patients
Beskrivning

Involuntary Commitment inpatient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021954
UMLS CUI [1,2]
C0021562
have a dsm-iv axis i diagnosis other than schizophrenia
Beskrivning

Axis I diagnosis | Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0036341
have a dsm-iv diagnosis of substance dependence within 3 months before screening (nicotine, caffeine dependence, and history of recreational use of marijuana are not exclusionary)
Beskrivning

Substance Dependence | Nicotine Dependence | Caffeine dependence | Marijuana Smoking

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
UMLS CUI [4]
C0024810
have a decrease of >/=25% in the panss score between screening and predose
Beskrivning

Positive and negative syndrome scale Decrease Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0547047
UMLS CUI [1,3]
C0439165
previous lack of response to 2 adequate trials of antipsychotic treatment
Beskrivning

Antipsychotic drug therapy Quantity | Poor response to treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1319421
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1320680
have a significant risk of suicidal, homicidal, or violent ideation or behavior
Beskrivning

Feeling suicidal Risk Significant | Suicidal behavior Risk Significant | Homicidal thoughts Risk Significant | Homicidal behavior Risk Significant | Violent ideation Risk Significant | Physical aggression Risk Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C1760428
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0750502
UMLS CUI [3,1]
C0455204
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0750502
UMLS CUI [4,1]
C1828354
UMLS CUI [4,2]
C0035647
UMLS CUI [4,3]
C0750502
UMLS CUI [5,1]
C1868823
UMLS CUI [5,2]
C0035647
UMLS CUI [5,3]
C0750502
UMLS CUI [6,1]
C0424323
UMLS CUI [6,2]
C0035647
UMLS CUI [6,3]
C0750502
have severe gastrointestinal narrowing (pathologic or iatrogenic)
Beskrivning

Gastrointestinal stenosis Pathologic | Gastrointestinal stenosis Iatrogenic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0521587
UMLS CUI [1,2]
C1521733
UMLS CUI [2,1]
C0521587
UMLS CUI [2,2]
C0439669
current presence of any significant or unstable medication condition
Beskrivning

Condition Pharmaceutical Preparations Significant | Condition Pharmaceutical Preparations Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0443343
treatment with any protocol disallowed therapies
Beskrivning

Therapeutic procedure Illicit Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332266
UMLS CUI [1,3]
C2348563
clinically significant result from screening laboratory or ecg.
Beskrivning

Result Clinical Significance Screening | Result Clinical Significance Laboratory Procedures | Result Clinical Significance Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0220908
UMLS CUI [2,1]
C0456984
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0022885
UMLS CUI [3,1]
C0456984
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C1623258
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Similar models

Eligibility Schizophrenia NCT00074477

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patients diagnosed with schizophrenia
boolean
C0036341 (UMLS CUI [1])
disease length
Item
for at least 1 year before screening
boolean
C0872146 (UMLS CUI [1])
Positive and negative syndrome scale criteria Fulfill
Item
meet panss score criteria
boolean
C0451383 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hospitalization Duration agreement
Item
must agree to hospitalization for a minimum of 14 days
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) <35.0 kilogram (kg)/meter (m)2.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Involuntary Commitment inpatient
Item
patients who are involuntarily committed as in-patients
boolean
C0021954 (UMLS CUI [1,1])
C0021562 (UMLS CUI [1,2])
Axis I diagnosis | Schizophrenia
Item
have a dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Substance Dependence | Nicotine Dependence | Caffeine dependence | Marijuana Smoking
Item
have a dsm-iv diagnosis of substance dependence within 3 months before screening (nicotine, caffeine dependence, and history of recreational use of marijuana are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
C0024810 (UMLS CUI [4])
Positive and negative syndrome scale Decrease Percentage
Item
have a decrease of >/=25% in the panss score between screening and predose
boolean
C0451383 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Antipsychotic drug therapy Quantity | Poor response to treatment
Item
previous lack of response to 2 adequate trials of antipsychotic treatment
boolean
C1319421 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [2])
Feeling suicidal Risk Significant | Suicidal behavior Risk Significant | Homicidal thoughts Risk Significant | Homicidal behavior Risk Significant | Violent ideation Risk Significant | Physical aggression Risk Significant
Item
have a significant risk of suicidal, homicidal, or violent ideation or behavior
boolean
C0424000 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C1760428 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0455204 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
C1828354 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0750502 (UMLS CUI [4,3])
C1868823 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0750502 (UMLS CUI [5,3])
C0424323 (UMLS CUI [6,1])
C0035647 (UMLS CUI [6,2])
C0750502 (UMLS CUI [6,3])
Gastrointestinal stenosis Pathologic | Gastrointestinal stenosis Iatrogenic
Item
have severe gastrointestinal narrowing (pathologic or iatrogenic)
boolean
C0521587 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C0521587 (UMLS CUI [2,1])
C0439669 (UMLS CUI [2,2])
Condition Pharmaceutical Preparations Significant | Condition Pharmaceutical Preparations Unstable
Item
current presence of any significant or unstable medication condition
boolean
C0348080 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Therapeutic procedure Illicit Study Protocol
Item
treatment with any protocol disallowed therapies
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Result Clinical Significance Screening | Result Clinical Significance Laboratory Procedures | Result Clinical Significance Electrocardiography
Item
clinically significant result from screening laboratory or ecg.
boolean
C0456984 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0456984 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
C0456984 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C1623258 (UMLS CUI [3,3])
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