ID

17124

Beskrivning

Memantine as an Adjunctive Agent to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Severe Major Depressive Episode; ODM derived from: https://clinicaltrials.gov/show/NCT00186498

Länk

https://clinicaltrials.gov/show/NCT00186498

Nyckelord

Versioner (1)
  1. 2016-08-25 2016-08-25 -
Uppladdad den

25 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT00186498

Engelsk

Eligibility Depressive Disorder, Major NCT00186498

1 Formulär  
Criteria
Beskrivning

Criteria

meets dsm-iv criteria for major depressive disorder
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
18 to 75 years of age and able to provide legal consent
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
referred to stanford ect service by treating physician for unilateral electroconvulsive therapy with inpatient hospitalization
Beskrivning

Referral for Electroconvulsive Therapy Unilateral | Hospitalization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C0013806
UMLS CUI [1,3]
C0205092
UMLS CUI [2]
C0019993
competed process for consenting to the clinical use of ect according to california state law
Beskrivning

Electroconvulsive Therapy Consent Use Clinical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013806
UMLS CUI [1,2]
C1511481
UMLS CUI [1,3]
C0457083
UMLS CUI [1,4]
C0205210
females of childbearing potential will be required to use a double-barrier method of contraception, which includes foam and either condom and diaphragm, iud, and/or implant during study. exclusion criteria:- treatment with ect in the 6 months prior to screening
Beskrivning

Childbearing Potential Contraceptive methods | Contraception, Barrier | Vaginal Foam | Female Condoms | Vaginal contraceptive diaphragm | Intrauterine Devices | Contraceptive implant | Exclusion Criteria | Electroconvulsive Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0004764
UMLS CUI [3]
C0042254
UMLS CUI [4]
C0221829
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0021900
UMLS CUI [7]
C1657106
UMLS CUI [8]
C0680251
UMLS CUI [9]
C0013806
meets criteria for drug or alcohol abuse or dependence in the 6 months prior to screening
Beskrivning

Substance Use Disorders | Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
use of alcohol or illegal drugs within seven days of randomization or during study. patients may be excluded for use during a period greater than 7 days, per study physician's discretion
Beskrivning

Alcohol consumption | Illicit drug use

Datatyp

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C0281875
presence of unstable or untreated cardiovascular disease, hypertension, or endocrine disorder as determined by the investigator
Beskrivning

Cardiovascular Disease Unstable | Hypertensive disease Unstable | Endocrine System Disease Unstable | Cardiovascular Disease untreated | hypertension untreated | Endocrine System Disease untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0014130
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0007222
UMLS CUI [4,2]
C0332155
UMLS CUI [5]
C0745134
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C0332155
use of antipsychotic, antidepressant, or other prescription medications unless dose is stable for at least 7 days prior to randomization.
Beskrivning

Antipsychotic Agents | Antidepressive Agents | Prescription medication Dosage Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C0003289
UMLS CUI [3,1]
C0033080
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0443343
use of any investigational treatment within 30 days of randomization
Beskrivning

Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0949266
previous allergic reaction to memantine or drugs of similar chemical structure.
Beskrivning

Allergic Reaction Memantine | Allergic Reaction Pharmaceutical Preparations Chemical Structure Similar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0025242
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0220807
UMLS CUI [2,4]
C2348205
women who are pregnant or breastfeeding are not advised to participate in the research study
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any neurological disorder or organic brain condition that would confound neurocognitive testing
Beskrivning

nervous system disorder Interferes with neurocognitive test | Organic brain disorder Interferes with neurocognitive test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0872227
UMLS CUI [2,1]
C4062280
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0872227
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Similar models

Eligibility Depressive Disorder, Major NCT00186498

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Major Depressive Disorder
Item
meets dsm-iv criteria for major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Age | Informed Consent
Item
18 to 75 years of age and able to provide legal consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Referral for Electroconvulsive Therapy Unilateral | Hospitalization
Item
referred to stanford ect service by treating physician for unilateral electroconvulsive therapy with inpatient hospitalization
boolean
C2585524 (UMLS CUI [1,1])
C0013806 (UMLS CUI [1,2])
C0205092 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2])
Electroconvulsive Therapy Consent Use Clinical
Item
competed process for consenting to the clinical use of ect according to california state law
boolean
C0013806 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
Childbearing Potential Contraceptive methods | Contraception, Barrier | Vaginal Foam | Female Condoms | Vaginal contraceptive diaphragm | Intrauterine Devices | Contraceptive implant | Exclusion Criteria | Electroconvulsive Therapy
Item
females of childbearing potential will be required to use a double-barrier method of contraception, which includes foam and either condom and diaphragm, iud, and/or implant during study. exclusion criteria:- treatment with ect in the 6 months prior to screening
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2])
C0042254 (UMLS CUI [3])
C0221829 (UMLS CUI [4])
C0042241 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C0680251 (UMLS CUI [8])
C0013806 (UMLS CUI [9])
Substance Use Disorders | Substance Dependence
Item
meets criteria for drug or alcohol abuse or dependence in the 6 months prior to screening
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Alcohol consumption | Illicit drug use
Item
use of alcohol or illegal drugs within seven days of randomization or during study. patients may be excluded for use during a period greater than 7 days, per study physician's discretion
boolean
C0001948 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
Cardiovascular Disease Unstable | Hypertensive disease Unstable | Endocrine System Disease Unstable | Cardiovascular Disease untreated | hypertension untreated | Endocrine System Disease untreated
Item
presence of unstable or untreated cardiovascular disease, hypertension, or endocrine disorder as determined by the investigator
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0014130 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0007222 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0745134 (UMLS CUI [5])
C0014130 (UMLS CUI [6,1])
C0332155 (UMLS CUI [6,2])
Antipsychotic Agents | Antidepressive Agents | Prescription medication Dosage Unstable
Item
use of antipsychotic, antidepressant, or other prescription medications unless dose is stable for at least 7 days prior to randomization.
boolean
C0040615 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0033080 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0443343 (UMLS CUI [3,4])
Therapy, Investigational
Item
use of any investigational treatment within 30 days of randomization
boolean
C0949266 (UMLS CUI [1])
Allergic Reaction Memantine | Allergic Reaction Pharmaceutical Preparations Chemical Structure Similar
Item
previous allergic reaction to memantine or drugs of similar chemical structure.
boolean
C1527304 (UMLS CUI [1,1])
C0025242 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding are not advised to participate in the research study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
nervous system disorder Interferes with neurocognitive test | Organic brain disorder Interferes with neurocognitive test
Item
any neurological disorder or organic brain condition that would confound neurocognitive testing
boolean
C0027765 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0872227 (UMLS CUI [1,3])
C4062280 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0872227 (UMLS CUI [2,3])
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