ID

35664

Beskrivning

Electrical Stimulation in Patients With Unipolar Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02239809

Länk

https://clinicaltrials.gov/show/NCT02239809

Nyckelord

Versioner (1)
  1. 2019-03-14 2019-03-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depression NCT02239809

Engelsk

Eligibility Depression NCT02239809

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02239809
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients with non-psychotic, unipolar major depressive disorder assessed via the mini structured interview and legally capacitated to sign the informed consent for participation in the study;
Beskrivning

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Unipolar | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0743081
UMLS CUI [1,2]
C0443340
UMLS CUI [2]
C0021430
a score of ≥ 14 on the ham-d17 with item 1 (depressed mood) ≥ 2;
Beskrivning

Hamilton Depression Rating Scale 17 Item Clinical Classification | Depressed mood

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2]
C0344315
a history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study);
Beskrivning

Treatment failure | Antidepressive Agents Quantity | Pharmaceutical Preparations Quantity | Antidepressive Agents Unchanged | Dosage Unchanged

Datatyp

boolean

Alias
UMLS CUI [1]
C0162643
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0003289
UMLS CUI [4,2]
C0442739
UMLS CUI [5,1]
C0178602
UMLS CUI [5,2]
C0442739
patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm and lack of self-harming attempt in the past 6 months;
Beskrivning

Feeling suicidal | Self-harm Plan Absent | Self-harm Intention Absent | Self-harm Attempt Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2,1]
C0424366
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0424366
UMLS CUI [3,2]
C1283828
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0424366
UMLS CUI [4,2]
C1516084
UMLS CUI [4,3]
C0332268
patients with appropriate support to be compliant with the study protocol.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is mentally or legally incapacitated, unable to give informed consent.
Beskrivning

Mental impairment | Legal capacity Lacking | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0683322
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded.
Beskrivning

Psychotic Disorders | Depression, psychotic | Schizophrenia | Schizoaffective Disorder Lifetime | Bipolar Disorder Lifetime | Dementia Lifetime | Delirium | Substance Use Disorders | Eating Disorders | Obsessive-Compulsive Disorder Lifetime | Post-Traumatic Stress Disorder | At risk for suicide | At risk of self-injurious behavior | Uncertainty Diagnostic | Ambiguity Diagnostic

Datatyp

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0743072
UMLS CUI [3]
C0036341
UMLS CUI [4,1]
C0036337
UMLS CUI [4,2]
C4071830
UMLS CUI [5,1]
C0005586
UMLS CUI [5,2]
C4071830
UMLS CUI [6,1]
C0497327
UMLS CUI [6,2]
C4071830
UMLS CUI [7]
C0011206
UMLS CUI [8]
C0038586
UMLS CUI [9]
C0013473
UMLS CUI [10,1]
C0028768
UMLS CUI [10,2]
C4071830
UMLS CUI [11]
C0038436
UMLS CUI [12]
C0563664
UMLS CUI [13]
C3875124
UMLS CUI [14,1]
C0087130
UMLS CUI [14,2]
C0348026
UMLS CUI [15,1]
C2346729
UMLS CUI [15,2]
C0348026
patients currently receiving more than six medications for treatment of mdd;
Beskrivning

Pharmaceutical Preparations Quantity Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1269683
patients with exposure to ect or rtms or any investigational treatment (for any disorder) within the past 6 months;
Beskrivning

Exposure to Electroconvulsive Therapy | Exposure to Repetitive Transcranial Magnetic Stimulation | Exposure to Investigational Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013806
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0872259
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0949266
prior vns and/or dbs therapy (lifetime);
Beskrivning

Vagus Nerve Stimulation Lifetime | Deep Brain Stimulation Lifetime

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2350432
UMLS CUI [1,2]
C4071830
UMLS CUI [2,1]
C0394162
UMLS CUI [2,2]
C4071830
past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, cva, or tias; cerebral aneurysm; parkinson's or huntington's disease; or multiple sclerosis;
Beskrivning

Skull Fracture | Cranial surgery Calvarium | Intracranial space-occupying lesion | Cerebrovascular accident | Transient Ischemic Attack | Cerebral Aneurysm | Parkinson Disease | Huntington Disease | Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0037304
UMLS CUI [2,1]
C2224798
UMLS CUI [2,2]
C0205950
UMLS CUI [3]
C0495785
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0007787
UMLS CUI [6]
C0917996
UMLS CUI [7]
C0030567
UMLS CUI [8]
C0020179
UMLS CUI [9]
C0026769
current pregnancy, breast feeding, plans to become pregnant during the study, or not using a medically accepted means of contraception;
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.
Beskrivning

Other medical condition At risk Communicable Disease | Morbidity Surgical Related | Other medical condition Affecting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0009450
UMLS CUI [2,1]
C0220880
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0525058
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Similar models

Eligibility Depression NCT02239809

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02239809
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Unipolar | Informed Consent
Item
outpatients with non-psychotic, unipolar major depressive disorder assessed via the mini structured interview and legally capacitated to sign the informed consent for participation in the study;
boolean
C0743081 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Depressed mood
Item
a score of ≥ 14 on the ham-d17 with item 1 (depressed mood) ≥ 2;
boolean
C3639712 (UMLS CUI [1])
C0344315 (UMLS CUI [2])
Treatment failure | Antidepressive Agents Quantity | Pharmaceutical Preparations Quantity | Antidepressive Agents Unchanged | Dosage Unchanged
Item
a history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study);
boolean
C0162643 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003289 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])
C0178602 (UMLS CUI [5,1])
C0442739 (UMLS CUI [5,2])
Feeling suicidal | Self-harm Plan Absent | Self-harm Intention Absent | Self-harm Attempt Lacking
Item
patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm and lack of self-harming attempt in the past 6 months;
boolean
C0424000 (UMLS CUI [1])
C0424366 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0424366 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0424366 (UMLS CUI [4,1])
C1516084 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
Protocol Compliance
Item
patients with appropriate support to be compliant with the study protocol.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental impairment | Legal capacity Lacking | Informed Consent Unable
Item
patient is mentally or legally incapacitated, unable to give informed consent.
boolean
C0683322 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Psychotic Disorders | Depression, psychotic | Schizophrenia | Schizoaffective Disorder Lifetime | Bipolar Disorder Lifetime | Dementia Lifetime | Delirium | Substance Use Disorders | Eating Disorders | Obsessive-Compulsive Disorder Lifetime | Post-Traumatic Stress Disorder | At risk for suicide | At risk of self-injurious behavior | Uncertainty Diagnostic | Ambiguity Diagnostic
Item
patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded.
boolean
C0033975 (UMLS CUI [1])
C0743072 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0005586 (UMLS CUI [5,1])
C4071830 (UMLS CUI [5,2])
C0497327 (UMLS CUI [6,1])
C4071830 (UMLS CUI [6,2])
C0011206 (UMLS CUI [7])
C0038586 (UMLS CUI [8])
C0013473 (UMLS CUI [9])
C0028768 (UMLS CUI [10,1])
C4071830 (UMLS CUI [10,2])
C0038436 (UMLS CUI [11])
C0563664 (UMLS CUI [12])
C3875124 (UMLS CUI [13])
C0087130 (UMLS CUI [14,1])
C0348026 (UMLS CUI [14,2])
C2346729 (UMLS CUI [15,1])
C0348026 (UMLS CUI [15,2])
Pharmaceutical Preparations Quantity Major Depressive Disorder
Item
patients currently receiving more than six medications for treatment of mdd;
boolean
C0013227 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1269683 (UMLS CUI [1,3])
Exposure to Electroconvulsive Therapy | Exposure to Repetitive Transcranial Magnetic Stimulation | Exposure to Investigational Therapy
Item
patients with exposure to ect or rtms or any investigational treatment (for any disorder) within the past 6 months;
boolean
C0332157 (UMLS CUI [1,1])
C0013806 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0872259 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0949266 (UMLS CUI [3,2])
Vagus Nerve Stimulation Lifetime | Deep Brain Stimulation Lifetime
Item
prior vns and/or dbs therapy (lifetime);
boolean
C2350432 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0394162 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
Skull Fracture | Cranial surgery Calvarium | Intracranial space-occupying lesion | Cerebrovascular accident | Transient Ischemic Attack | Cerebral Aneurysm | Parkinson Disease | Huntington Disease | Multiple Sclerosis
Item
past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, cva, or tias; cerebral aneurysm; parkinson's or huntington's disease; or multiple sclerosis;
boolean
C0037304 (UMLS CUI [1])
C2224798 (UMLS CUI [2,1])
C0205950 (UMLS CUI [2,2])
C0495785 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0917996 (UMLS CUI [6])
C0030567 (UMLS CUI [7])
C0020179 (UMLS CUI [8])
C0026769 (UMLS CUI [9])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
current pregnancy, breast feeding, plans to become pregnant during the study, or not using a medically accepted means of contraception;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Other medical condition At risk Communicable Disease | Morbidity Surgical Related | Other medical condition Affecting Protocol Compliance
Item
other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0220880 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
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