ID

37195

Descrição

Bifrontal and Bitemporal Electroconvulsive Therapy (ECT) in Treatment of Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT02511509

Link

https://clinicaltrials.gov/show/NCT02511509

Palavras-chave

Versões (1)
  1. 07/07/2019 07/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02511509

Inglês

Eligibility Schizophrenia NCT02511509

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patients who met diagnostic and statistical manual-dsm-v criteria for schizophrenia (apart from residual type)
Descrição

Schizophrenia | Exception Residual schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036351
the patients qualified for ect according the standard protocol
Descrição

Patients Appropriate Electroconvulsive Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0013806
antipsychotic treatment with dibenzepins according to the following scheme: the dose of clozapine not higher than 450mg, the dose of olanzapine not higher than 20mg and the dose of quetiapine not higher than 600mg per day
Descrição

Antipsychotic drug therapy | Dibenzepin | Clozapine Dose U/day | Olanzapine Dose U/day | Quetiapine Dose U/day

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1319421
UMLS CUI [2]
C0012030
UMLS CUI [3,1]
C0009079
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0456683
UMLS CUI [4,1]
C0171023
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0456683
UMLS CUI [5,1]
C0123091
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0456683
if needed concomitant treatment allowed with hydroxyzine (max. 100mg per day) and lorazepam (max. 4mg per day)
Descrição

Concomitant Therapy | Hydroxyzine U/day | Lorazepam U/day

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707479
UMLS CUI [2,1]
C0020404
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0024002
UMLS CUI [3,2]
C0456683
anaesthesia conducted with the use of suxamethonium chloride, propofol and atropine
Descrição

Anesthesia | Suxamethonium Chloride | Propofol | Atropine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002903
UMLS CUI [2]
C0012792
UMLS CUI [3]
C0033487
UMLS CUI [4]
C0004259
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
the lack of patient's consent
Descrição

Informed Consent Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
mental retardation confirmed with the psychological and psychiatric examination (iq<70; fulfilled dsm-v criteria for mental retardation)
Descrição

Mental Retardation Intelligence quotient | Psychological Test | Psychiatric examination

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025362
UMLS CUI [1,2]
C0456149
UMLS CUI [2]
C0033905
UMLS CUI [3]
C1405560
dementia diagnosed on the basis of dsm-v criteria
Descrição

Dementia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0497327
substance abuse during the year prior study enrolment or substance addiction
Descrição

Substance Use Disorders | Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
the presence of symptoms which met dsm-v criteria for affective episode (an episode of mania, hypomania or depression)
Descrição

Symptoms Affective episode | Manic episode | Hypomanic episode | Ddepressive episode

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1386525
UMLS CUI [2]
C0349208
UMLS CUI [3]
C1396834
UMLS CUI [4]
C0349216
the ect conducted during 6 months prior the study enrolment
Descrição

Electroconvulsive Therapy Recent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013806
UMLS CUI [1,2]
C0332185
the history of previous ineffective ect
Descrição

Electroconvulsive Therapy ineffective

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013806
UMLS CUI [1,2]
C3242229
the need for antipsychotic treatment other than derivatives of dibenzothiazepines or in doses higher than 450mg of clozapine, 20mg of olanzapine and 600mg of quetiapine per day
Descrição

Antipsychotic drug therapy | Exception Derivative Dibenzothiazepines | Exception Clozapine Dose U/day | Exception Olanzapine Dose U/day | Exception Quetiapine Dose U/day

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1319421
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1527240
UMLS CUI [2,3]
C0012033
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0009079
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0456683
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0171023
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0456683
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0123091
UMLS CUI [5,3]
C0178602
UMLS CUI [5,4]
C0456683
the women in the generative period who do not use effective contraception (sexual abstinence, contraceptives, intrauterine device, mechanical contraceptive devices)
Descrição

Childbearing Potential Contraceptive methods Absent | Sexual Abstinence | Contraceptive Agents | Intrauterine Devices | Contraceptive Devices, Female

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0036899
UMLS CUI [3]
C0009871
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0009887
the need for use of other than suxamethonium chloride, propofol and atropine anaesthetics and concomitant medications
Descrição

Anesthetics | Concomitant Agent | Exception Suxamethonium Chloride | Exception Propofol | Exception Atropine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002932
UMLS CUI [2]
C2347852
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012792
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0033487
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0004259
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Similar models

Eligibility Schizophrenia NCT02511509

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Exception Residual schizophrenia
Item
the patients who met diagnostic and statistical manual-dsm-v criteria for schizophrenia (apart from residual type)
boolean
C0036341 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036351 (UMLS CUI [2,2])
Patients Appropriate Electroconvulsive Therapy
Item
the patients qualified for ect according the standard protocol
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0013806 (UMLS CUI [1,3])
Antipsychotic drug therapy | Dibenzepin | Clozapine Dose U/day | Olanzapine Dose U/day | Quetiapine Dose U/day
Item
antipsychotic treatment with dibenzepins according to the following scheme: the dose of clozapine not higher than 450mg, the dose of olanzapine not higher than 20mg and the dose of quetiapine not higher than 600mg per day
boolean
C1319421 (UMLS CUI [1])
C0012030 (UMLS CUI [2])
C0009079 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C0171023 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
C0123091 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
Concomitant Therapy | Hydroxyzine U/day | Lorazepam U/day
Item
if needed concomitant treatment allowed with hydroxyzine (max. 100mg per day) and lorazepam (max. 4mg per day)
boolean
C1707479 (UMLS CUI [1])
C0020404 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0024002 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
Anesthesia | Suxamethonium Chloride | Propofol | Atropine
Item
anaesthesia conducted with the use of suxamethonium chloride, propofol and atropine
boolean
C0002903 (UMLS CUI [1])
C0012792 (UMLS CUI [2])
C0033487 (UMLS CUI [3])
C0004259 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Informed Consent Lacking
Item
the lack of patient's consent
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Mental Retardation Intelligence quotient | Psychological Test | Psychiatric examination
Item
mental retardation confirmed with the psychological and psychiatric examination (iq<70; fulfilled dsm-v criteria for mental retardation)
boolean
C0025362 (UMLS CUI [1,1])
C0456149 (UMLS CUI [1,2])
C0033905 (UMLS CUI [2])
C1405560 (UMLS CUI [3])
Dementia
Item
dementia diagnosed on the basis of dsm-v criteria
boolean
C0497327 (UMLS CUI [1])
Substance Use Disorders | Substance Dependence
Item
substance abuse during the year prior study enrolment or substance addiction
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Symptoms Affective episode | Manic episode | Hypomanic episode | Ddepressive episode
Item
the presence of symptoms which met dsm-v criteria for affective episode (an episode of mania, hypomania or depression)
boolean
C1457887 (UMLS CUI [1,1])
C1386525 (UMLS CUI [1,2])
C0349208 (UMLS CUI [2])
C1396834 (UMLS CUI [3])
C0349216 (UMLS CUI [4])
Electroconvulsive Therapy Recent
Item
the ect conducted during 6 months prior the study enrolment
boolean
C0013806 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Electroconvulsive Therapy ineffective
Item
the history of previous ineffective ect
boolean
C0013806 (UMLS CUI [1,1])
C3242229 (UMLS CUI [1,2])
Antipsychotic drug therapy | Exception Derivative Dibenzothiazepines | Exception Clozapine Dose U/day | Exception Olanzapine Dose U/day | Exception Quetiapine Dose U/day
Item
the need for antipsychotic treatment other than derivatives of dibenzothiazepines or in doses higher than 450mg of clozapine, 20mg of olanzapine and 600mg of quetiapine per day
boolean
C1319421 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
C0012033 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0009079 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0456683 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0171023 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0456683 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0123091 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
C0456683 (UMLS CUI [5,4])
Childbearing Potential Contraceptive methods Absent | Sexual Abstinence | Contraceptive Agents | Intrauterine Devices | Contraceptive Devices, Female
Item
the women in the generative period who do not use effective contraception (sexual abstinence, contraceptives, intrauterine device, mechanical contraceptive devices)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0036899 (UMLS CUI [2])
C0009871 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0009887 (UMLS CUI [5])
Anesthetics | Concomitant Agent | Exception Suxamethonium Chloride | Exception Propofol | Exception Atropine
Item
the need for use of other than suxamethonium chloride, propofol and atropine anaesthetics and concomitant medications
boolean
C0002932 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0012792 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0033487 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0004259 (UMLS CUI [5,2])
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