ID

19266

Description

Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00101634

Link

https://clinicaltrials.gov/show/NCT00101634

Keywords

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

December 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00101634

English

Eligibility Schizophrenia NCT00101634

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who meet diagnostic criteria for schizophrenia according to dsm-iv for at least 1 year
Description

Schizophrenia disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
meet panss score criteria
Description

Positive and negative syndrome scale criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
have body mass index (bmi) of >15.0 kilogram(kg)/meter (m)2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have primary active dsm-iv axis i diagnosis other than schizophrenia
Description

Axis I diagnosis Primary | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0036341
have a decrease of >/=25% in the panss score
Description

Positive and negative syndrome scale Decrease Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0547047
UMLS CUI [1,3]
C0439165
have dsm-iv diagnosis of active substance dependence within 3 months of 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
have history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
Description

Therapeutic procedure Resistance | Antipsychotic Agents Different Poor response to treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1514892
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C1705242
UMLS CUI [2,3]
C1320680
have any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
Description

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

Data type

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
have significant risk of suicidal, homicidal or violent ideation or behavior
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C0455204
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0750502
UMLS CUI [3,1]
C1868823
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0750502
UMLS CUI [4,1]
C1760428
UMLS CUI [4,2]
C0035647
UMLS CUI [4,3]
C0750502
UMLS CUI [5,1]
C1828354
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
current presence of any significant or unstable medication condition
Description

Pharmaceutical Preparations Condition Significant | Pharmaceutical Preparations Condition Unstable

Data type

boolean

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

Therapeutic procedure Illicit Study Protocol

Data type

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.
Description

Test Result Clinical Significance Screening procedure | Laboratory Test Result Clinically Significant | Test Result Clinical Significance Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0220908
UMLS CUI [2]
C2826633
UMLS CUI [3,1]
C0456984
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C1623258
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Similar models

Eligibility Schizophrenia NCT00101634

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia disease length
Item
patients who meet diagnostic criteria for schizophrenia according to dsm-iv for at least 1 year
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
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])
Body mass index
Item
have body mass index (bmi) of >15.0 kilogram(kg)/meter (m)2.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis Primary | Schizophrenia
Item
patients who have primary active dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
Positive and negative syndrome scale Decrease Percentage
Item
have a decrease of >/=25% in the panss score
boolean
C0451383 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
have dsm-iv diagnosis of active substance dependence within 3 months of screening evaluation (nicotine and caffeine dependence are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Therapeutic procedure Resistance | Antipsychotic Agents Different Poor response to treatment
Item
have history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
boolean
C0087111 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C1320680 (UMLS CUI [2,3])
Gastrointestinal stenosis Pathologic Pre-existing Severe | Gastrointestinal stenosis Iatrogenic Pre-existing Severe
Item
have 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])
Feeling suicidal Risk Significant | Homicidal thoughts Risk Significant | Violent ideation Risk Significant | Suicidal behavior Risk Significant | Homicidal behavior Risk Significant | Physical aggression Risk Significant
Item
have 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])
C0455204 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C1868823 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
C1760428 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0750502 (UMLS CUI [4,3])
C1828354 (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])
Pharmaceutical Preparations Condition Significant | Pharmaceutical Preparations Condition Unstable
Item
current presence of any significant or unstable medication condition
boolean
C0013227 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0348080 (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])
Test Result Clinical Significance Screening procedure | Laboratory Test Result Clinically Significant | Test 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])
C2826633 (UMLS CUI [2])
C0456984 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C1623258 (UMLS CUI [3,3])
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