ID

32113

Beschrijving

Efficacy Study on Cognitive Functions in Schizophrenic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00761670

Link

https://clinicaltrials.gov/show/NCT00761670

Trefwoorden

Versies (1)
  1. 18-10-18 18-10-18 -
Houder van rechten

See clinicaltrials.gov

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18 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00761670

Engels

Eligibility Schizophrenia NCT00761670

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis: dsm-iv schizophrenia (any subtype)
Beschrijving

Schizophrenia Subtype Any

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0449560
UMLS CUI [1,3]
C1552551
duration of illness: ≥ 5 years
Beschrijving

Disease length

Datatype

boolean

Alias
UMLS CUI [1]
C0872146
concomitant standing or prn medications (except other antipsychotics and those contraindicated in the respective package inserts [amisulpride or risperidone]) are permitted during treatment phase, if they were present at a stable dose for at least 6 weeks prior to the start of initial treatment with study medication
Beschrijving

Concomitant Agent Dose Stable | Exception Antipsychotic Agents Other | Exception Pharmaceutical Preparations Contraindicated

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0040615
UMLS CUI [2,3]
C0205394
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C1444657
overall symptom severity: patients must evidence a total score of 60 or higher on the panss scale
Beschrijving

Symptom severity Overall PANSS

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319166
UMLS CUI [1,2]
C1561607
UMLS CUI [1,3]
C4086747
clinical symptoms: a score of 4 (moderate) or greater on any of the 7 items of the panss positive symptom subscale is present
Beschrijving

Symptoms Clinical | PANSS Symptoms Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C4086747
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C1514241
cognitive status (minimum performance level): subject must be able to validly complete the baseline matrics assessment
Beschrijving

Cognitive status | Cognition Schizophrenia Assessment

Datatype

boolean

Alias
UMLS CUI [1]
C0945985
UMLS CUI [2,1]
C0009240
UMLS CUI [2,2]
C0036341
UMLS CUI [2,3]
C1516048
clinical judgment by the investigator that treatments with amisulpride or risperidone are warranted due to suboptimal clinical outcome despite previous treatments
Beschrijving

Amisulpride | Risperidone

Datatype

boolean

Alias
UMLS CUI [1]
C0103045
UMLS CUI [2]
C0073393
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
past or current intolerance of amisulpride or risperidone side effects that are judged by the investigator to be unsafe, dose-limiting, or likely to result in study discontinuation.
Beschrijving

Intolerance Amisulpride Side effects | Intolerance Risperidone Side effects

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231199
UMLS CUI [1,2]
C0103045
UMLS CUI [1,3]
C0879626
UMLS CUI [2,1]
C0231199
UMLS CUI [2,2]
C0073393
UMLS CUI [2,3]
C0879626
any contraindication for amisulpride or risperidone therapy as indicated in the drug description.
Beschrijving

Medical contraindication Amisulpride | Medical contraindication Risperidone

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0103045
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0073393
presence of any unstable or untreated medical disorder.
Beschrijving

Disease Unstable | Disease Untreated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332155
any history of seizures or seizure disorder other than febrile seizures of childhood;
Beschrijving

Seizures | Epilepsy | Exception Febrile seizures of childhood

Datatype

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0014544
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0009952
history of positive hepatitis b surface antigen.
Beschrijving

Hepatitis B surface antigen positive

Datatype

boolean

Alias
UMLS CUI [1]
C0149709
any abnormal laboratory test that is judged to be clinically significant by the investigator.
Beschrijving

Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0438215
a history of significant head injury/trauma, as defined by:
Beschrijving

Craniocerebral Trauma

Datatype

boolean

Alias
UMLS CUI [1]
C0018674
a. loss of consciousness (loc) for more than 1 hour b. recurring seizures resulting from the head injury c. clear cognitive sequelae of the injury d. cognitive rehabilitation following the injury
Beschrijving

Unconscious State Duration | Recurrent seizures Due to Craniocerebral Trauma | Sequelae Cognitive Due to Craniocerebral Trauma | Cognitive rehabilitation Following Craniocerebral Trauma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0041657
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0748607
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0018674
UMLS CUI [3,1]
C0243088
UMLS CUI [3,2]
C1516691
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0018674
UMLS CUI [4,1]
C0870303
UMLS CUI [4,2]
C0332282
UMLS CUI [4,3]
C0018674
alcohol or substance dependence within the past 12 months or abuse within the past 3 months. any subject with positive urine toxicology or alcohol use that is considered abnormal at baseline.
Beschrijving

Substance Dependence | Substance Use Disorders | Urine Toxicology Positive | Alcohol consumption Abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C0042036
UMLS CUI [3,2]
C0852616
UMLS CUI [3,3]
C1514241
UMLS CUI [4,1]
C0001948
UMLS CUI [4,2]
C0205161
clinically significant suicidal or homicidal behavior or attempts within past 6 months.
Beschrijving

Suicidal behavior | Homicidal behavior | Suicide attempt | Homicide attempt

Datatype

boolean

Alias
UMLS CUI [1]
C1760428
UMLS CUI [2]
C1828354
UMLS CUI [3]
C0038663
UMLS CUI [4]
C0277662
pregnant or breast-feeding women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
absence of medically approved contraceptive methods for female of childbearing potential.
Beschrijving

Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschrijving

Study Subject Participation Status | Considerations Additional

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Schizophrenia NCT00761670

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia Subtype Any
Item
diagnosis: dsm-iv schizophrenia (any subtype)
boolean
C0036341 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Disease length
Item
duration of illness: ≥ 5 years
boolean
C0872146 (UMLS CUI [1])
Concomitant Agent Dose Stable | Exception Antipsychotic Agents Other | Exception Pharmaceutical Preparations Contraindicated
Item
concomitant standing or prn medications (except other antipsychotics and those contraindicated in the respective package inserts [amisulpride or risperidone]) are permitted during treatment phase, if they were present at a stable dose for at least 6 weeks prior to the start of initial treatment with study medication
boolean
C2347852 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0040615 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1444657 (UMLS CUI [3,3])
Symptom severity Overall PANSS
Item
overall symptom severity: patients must evidence a total score of 60 or higher on the panss scale
boolean
C1319166 (UMLS CUI [1,1])
C1561607 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Symptoms Clinical | PANSS Symptoms Positive
Item
clinical symptoms: a score of 4 (moderate) or greater on any of the 7 items of the panss positive symptom subscale is present
boolean
C1457887 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C4086747 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Cognitive status | Cognition Schizophrenia Assessment
Item
cognitive status (minimum performance level): subject must be able to validly complete the baseline matrics assessment
boolean
C0945985 (UMLS CUI [1])
C0009240 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
Amisulpride | Risperidone
Item
clinical judgment by the investigator that treatments with amisulpride or risperidone are warranted due to suboptimal clinical outcome despite previous treatments
boolean
C0103045 (UMLS CUI [1])
C0073393 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Intolerance Amisulpride Side effects | Intolerance Risperidone Side effects
Item
past or current intolerance of amisulpride or risperidone side effects that are judged by the investigator to be unsafe, dose-limiting, or likely to result in study discontinuation.
boolean
C0231199 (UMLS CUI [1,1])
C0103045 (UMLS CUI [1,2])
C0879626 (UMLS CUI [1,3])
C0231199 (UMLS CUI [2,1])
C0073393 (UMLS CUI [2,2])
C0879626 (UMLS CUI [2,3])
Medical contraindication Amisulpride | Medical contraindication Risperidone
Item
any contraindication for amisulpride or risperidone therapy as indicated in the drug description.
boolean
C1301624 (UMLS CUI [1,1])
C0103045 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0073393 (UMLS CUI [2,2])
Disease Unstable | Disease Untreated
Item
presence of any unstable or untreated medical disorder.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Seizures | Epilepsy | Exception Febrile seizures of childhood
Item
any history of seizures or seizure disorder other than febrile seizures of childhood;
boolean
C0036572 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0009952 (UMLS CUI [3,2])
Hepatitis B surface antigen positive
Item
history of positive hepatitis b surface antigen.
boolean
C0149709 (UMLS CUI [1])
Laboratory test result abnormal
Item
any abnormal laboratory test that is judged to be clinically significant by the investigator.
boolean
C0438215 (UMLS CUI [1])
Craniocerebral Trauma
Item
a history of significant head injury/trauma, as defined by:
boolean
C0018674 (UMLS CUI [1])
Unconscious State Duration | Recurrent seizures Due to Craniocerebral Trauma | Sequelae Cognitive Due to Craniocerebral Trauma | Cognitive rehabilitation Following Craniocerebral Trauma
Item
a. loss of consciousness (loc) for more than 1 hour b. recurring seizures resulting from the head injury c. clear cognitive sequelae of the injury d. cognitive rehabilitation following the injury
boolean
C0041657 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0748607 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0018674 (UMLS CUI [2,3])
C0243088 (UMLS CUI [3,1])
C1516691 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0018674 (UMLS CUI [3,4])
C0870303 (UMLS CUI [4,1])
C0332282 (UMLS CUI [4,2])
C0018674 (UMLS CUI [4,3])
Substance Dependence | Substance Use Disorders | Urine Toxicology Positive | Alcohol consumption Abnormal
Item
alcohol or substance dependence within the past 12 months or abuse within the past 3 months. any subject with positive urine toxicology or alcohol use that is considered abnormal at baseline.
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0042036 (UMLS CUI [3,1])
C0852616 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
C0001948 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
Suicidal behavior | Homicidal behavior | Suicide attempt | Homicide attempt
Item
clinically significant suicidal or homicidal behavior or attempts within past 6 months.
boolean
C1760428 (UMLS CUI [1])
C1828354 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
C0277662 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
absence of medically approved contraceptive methods for female of childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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