ID

32013

Description

Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone; ODM derived from: https://clinicaltrials.gov/show/NCT00480844

Link

https://clinicaltrials.gov/show/NCT00480844

Keywords

Versions (1)
  1. 10/12/18 10/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00480844

English

Eligibility Schizophrenia NCT00480844

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients suffering from schizophrenia (dsm iv).
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
failure of at least one previous antipsychotic for intolerance.
Description

Antipsychotic Agents Quantity failed | Intolerance to Antipsychotic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0040615
psychotic symptoms that are not secondary to a general medical condition or substance abuse.
Description

Psychotic symptom Independent of Other medical condition | Psychotic symptom Independent of Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C3843040
UMLS CUI [2,1]
C0871189
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0038586
ages between 18-65 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients receiving other psychotropic medications (anti-depressants, mood stabilizers, sedatives, hypnotics) must be on a stable dose for at least 2 weeks before entering the trial.
Description

Psychotropic Drugs Dose Stable | Antidepressive Agents | Mood Stabilizer | Sedatives | Hypnotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0003289
UMLS CUI [3]
C2917435
UMLS CUI [4]
C0036557
UMLS CUI [5]
C0020591
able to understand and sign an informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients suffering from psychotic disorders caused by a general medical condition.
Description

Psychotic Disorders caused by Medical condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C3843040
patients having high suicidal risk, as measured by score of 2 or more in cdss -
Description

High suicide risk Depression scale Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C1271074
UMLS CUI [1,2]
C0679604
UMLS CUI [1,3]
C0036341
calgary depression scale for schizophrenia.
Description

Depression scale Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0679604
UMLS CUI [1,2]
C0036341
patients suffering from an unstable clinically significant medical condition (endocrine, nutritional, hepatic, urinary).
Description

Medical condition Unstable | Endocrine System Diseases | Nutrition Disorders | Liver diseases | Urologic Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0014130
UMLS CUI [3]
C3714509
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0042075
significant cardiovascular illness, and/or qt prolongation at screening (more then 450 msec for male or 470 msec for female).
Description

Cardiovascular Disease | Prolonged QT interval | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0151878
UMLS CUI [3]
C0079399
patients suffering from a malignancy or neuro-degenerative illness (e.g. parkinsons'
Description

Malignant Neoplasms | Neurodegenerative Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0524851
disease)
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
patients suffering from organic brain disorders, including epilepsy and mental retardation.
Description

Organic brain disorder | Epilepsy | Mental Retardation

Data type

boolean

Alias
UMLS CUI [1]
C4062280
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0025362
patients suffering from a clinically significant mood disorder.
Description

Mood Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0525045
pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
history of drug or alcohol dependence within the last year.
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
previous documented non-response to risperidone.
Description

Risperidone Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C0205269
patients using medicinal products that are contraindicated with sertindole and/or risperidone.
Description

Pharmaceutical Preparations Contraindicated Sertindole | Pharmaceutical Preparations Contraindicated Risperidone

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0084528
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444657
UMLS CUI [2,3]
C0073393
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Similar models

Eligibility Schizophrenia NCT00480844

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patients suffering from schizophrenia (dsm iv).
boolean
C0036341 (UMLS CUI [1])
Antipsychotic Agents Quantity failed | Intolerance to Antipsychotic Agents
Item
failure of at least one previous antipsychotic for intolerance.
boolean
C0040615 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0040615 (UMLS CUI [2,2])
Psychotic symptom Independent of Other medical condition | Psychotic symptom Independent of Substance Use Disorders
Item
psychotic symptoms that are not secondary to a general medical condition or substance abuse.
boolean
C0871189 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
C0871189 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0038586 (UMLS CUI [2,3])
Age
Item
ages between 18-65 years old.
boolean
C0001779 (UMLS CUI [1])
Psychotropic Drugs Dose Stable | Antidepressive Agents | Mood Stabilizer | Sedatives | Hypnotics
Item
patients receiving other psychotropic medications (anti-depressants, mood stabilizers, sedatives, hypnotics) must be on a stable dose for at least 2 weeks before entering the trial.
boolean
C0033978 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2])
C2917435 (UMLS CUI [3])
C0036557 (UMLS CUI [4])
C0020591 (UMLS CUI [5])
Informed Consent
Item
able to understand and sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Psychotic Disorders caused by Medical condition
Item
patients suffering from psychotic disorders caused by a general medical condition.
boolean
C0033975 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
High suicide risk Depression scale Schizophrenia
Item
patients having high suicidal risk, as measured by score of 2 or more in cdss -
boolean
C1271074 (UMLS CUI [1,1])
C0679604 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Depression scale Schizophrenia
Item
calgary depression scale for schizophrenia.
boolean
C0679604 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
Medical condition Unstable | Endocrine System Diseases | Nutrition Disorders | Liver diseases | Urologic Diseases
Item
patients suffering from an unstable clinically significant medical condition (endocrine, nutritional, hepatic, urinary).
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0014130 (UMLS CUI [2])
C3714509 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0042075 (UMLS CUI [5])
Cardiovascular Disease | Prolonged QT interval | Gender
Item
significant cardiovascular illness, and/or qt prolongation at screening (more then 450 msec for male or 470 msec for female).
boolean
C0007222 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Malignant Neoplasms | Neurodegenerative Disorders
Item
patients suffering from a malignancy or neuro-degenerative illness (e.g. parkinsons'
boolean
C0006826 (UMLS CUI [1])
C0524851 (UMLS CUI [2])
Parkinson Disease
Item
disease)
boolean
C0030567 (UMLS CUI [1])
Organic brain disorder | Epilepsy | Mental Retardation
Item
patients suffering from organic brain disorders, including epilepsy and mental retardation.
boolean
C4062280 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0025362 (UMLS CUI [3])
Mood Disorders
Item
patients suffering from a clinically significant mood disorder.
boolean
C0525045 (UMLS CUI [1])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Substance Dependence
Item
history of drug or alcohol dependence within the last year.
boolean
C0038580 (UMLS CUI [1])
Risperidone Unresponsive to Treatment
Item
previous documented non-response to risperidone.
boolean
C0073393 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Pharmaceutical Preparations Contraindicated Sertindole | Pharmaceutical Preparations Contraindicated Risperidone
Item
patients using medicinal products that are contraindicated with sertindole and/or risperidone.
boolean
C0013227 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0084528 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
C0073393 (UMLS CUI [2,3])
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