ID

32258

Beschrijving

Treatment Strategy for Refractory Schizophrenia: Drug Interaction Between Clozapine and Fluvoxamine; ODM derived from: https://clinicaltrials.gov/show/NCT01401491

Link

https://clinicaltrials.gov/show/NCT01401491

Trefwoorden

Versies (1)
  1. 25-10-18 25-10-18 -
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See clinicaltrials.gov

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25 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01401491

Engels

Eligibility Schizophrenia NCT01401491

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. inpatients meet the dsm-iv criteria for schizophrenia.
Beschrijving

Inpatient | Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2]
C0036341
2. treatment refractoriness: failed to respond to at least two typical neuroleptics at dosage equivalent to or greater than 1000 mg/day of chlorpromazine for a period of at least six weeks.
Beschrijving

Unresponsive to Treatment | Antipsychotic Agents Quantity failed | Dosage Equivalent Chlorpromazine U/day | Dosage Greater Than Chlorpromazine U/day

Datatype

boolean

Alias
UMLS CUI [1]
C0205269
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0205163
UMLS CUI [3,3]
C0008286
UMLS CUI [3,4]
C0456683
UMLS CUI [4,1]
C0178602
UMLS CUI [4,2]
C0439093
UMLS CUI [4,3]
C0008286
UMLS CUI [4,4]
C0456683
3. age 18-60 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
4. males or females.
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
5. total panss score >60
Beschrijving

PANSS

Datatype

boolean

Alias
UMLS CUI [1]
C4086747
6. good physical health determined by complete physical examination, laboratory tests, and ekg.
Beschrijving

Physical Well-being Complete physical examination | Physical Well-being Laboratory Procedures | Physical Well-being EKG

Datatype

boolean

Alias
UMLS CUI [1,1]
C0517226
UMLS CUI [1,2]
C0436120
UMLS CUI [2,1]
C0517226
UMLS CUI [2,2]
C0022885
UMLS CUI [3,1]
C0517226
UMLS CUI [3,2]
C0013798
7. capacity and willingness to give written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of illicit substance abuse or dependence
Beschrijving

Substance Use Disorders Illicit Substance | Substance Dependence Illicit Substance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C2697662
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C2697662
2. history of clozapine intolerance (such as clinically significant leukopenia or agranulocytosis).
Beschrijving

Intolerance to Clozapine | Leukopenia | Agranulocytosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0009079
UMLS CUI [2]
C0023530
UMLS CUI [3]
C0001824
3. patients with wbc count less than 3500/mm3 or anc count less than 2000/mm3will not be included.
Beschrijving

White Blood Cell Count procedure | Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
4. any depot neuroleptics within 30 days before the day of randomization.
Beschrijving

Injection of depot antipsychotic agent

Datatype

boolean

Alias
UMLS CUI [1]
C2585377
5. epilepsy, active hepatitis, hiv positivity, or current myeloproliferative disorder. other medical illnesses may necessitate subjects' exclusion after evaluation of individual cases by the principal investigator and other staffs. clinical judgment will be used.
Beschrijving

Epilepsy | Hepatitis | HIV Seropositivity | Myeloproliferative disease | Illness Study Subject Participation Status Exclusion | Status post Patient evaluation

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0019699
UMLS CUI [4]
C0027022
UMLS CUI [5,1]
C0221423
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C2828389
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C0679830
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Similar models

Eligibility Schizophrenia NCT01401491

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Inpatient | Schizophrenia
Item
1. inpatients meet the dsm-iv criteria for schizophrenia.
boolean
C0021562 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Unresponsive to Treatment | Antipsychotic Agents Quantity failed | Dosage Equivalent Chlorpromazine U/day | Dosage Greater Than Chlorpromazine U/day
Item
2. treatment refractoriness: failed to respond to at least two typical neuroleptics at dosage equivalent to or greater than 1000 mg/day of chlorpromazine for a period of at least six weeks.
boolean
C0205269 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0178602 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0008286 (UMLS CUI [3,3])
C0456683 (UMLS CUI [3,4])
C0178602 (UMLS CUI [4,1])
C0439093 (UMLS CUI [4,2])
C0008286 (UMLS CUI [4,3])
C0456683 (UMLS CUI [4,4])
Age
Item
3. age 18-60 years.
boolean
C0001779 (UMLS CUI [1])
Gender
Item
4. males or females.
boolean
C0079399 (UMLS CUI [1])
PANSS
Item
5. total panss score >60
boolean
C4086747 (UMLS CUI [1])
Physical Well-being Complete physical examination | Physical Well-being Laboratory Procedures | Physical Well-being EKG
Item
6. good physical health determined by complete physical examination, laboratory tests, and ekg.
boolean
C0517226 (UMLS CUI [1,1])
C0436120 (UMLS CUI [1,2])
C0517226 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C0517226 (UMLS CUI [3,1])
C0013798 (UMLS CUI [3,2])
Informed Consent
Item
7. capacity and willingness to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders Illicit Substance | Substance Dependence Illicit Substance
Item
1. history of illicit substance abuse or dependence
boolean
C0038586 (UMLS CUI [1,1])
C2697662 (UMLS CUI [1,2])
C0038580 (UMLS CUI [2,1])
C2697662 (UMLS CUI [2,2])
Intolerance to Clozapine | Leukopenia | Agranulocytosis
Item
2. history of clozapine intolerance (such as clinically significant leukopenia or agranulocytosis).
boolean
C1744706 (UMLS CUI [1,1])
C0009079 (UMLS CUI [1,2])
C0023530 (UMLS CUI [2])
C0001824 (UMLS CUI [3])
White Blood Cell Count procedure | Absolute neutrophil count
Item
3. patients with wbc count less than 3500/mm3 or anc count less than 2000/mm3will not be included.
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Injection of depot antipsychotic agent
Item
4. any depot neuroleptics within 30 days before the day of randomization.
boolean
C2585377 (UMLS CUI [1])
Epilepsy | Hepatitis | HIV Seropositivity | Myeloproliferative disease | Illness Study Subject Participation Status Exclusion | Status post Patient evaluation
Item
5. epilepsy, active hepatitis, hiv positivity, or current myeloproliferative disorder. other medical illnesses may necessitate subjects' exclusion after evaluation of individual cases by the principal investigator and other staffs. clinical judgment will be used.
boolean
C0014544 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
C0027022 (UMLS CUI [4])
C0221423 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C2828389 (UMLS CUI [5,3])
C0231290 (UMLS CUI [6,1])
C0679830 (UMLS CUI [6,2])
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