ID

28893

Beskrivning

Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00956514

Länk

https://clinicaltrials.gov/show/NCT00956514

Nyckelord

Versioner (1)
  1. 2018-02-13 2018-02-13 -
Rättsinnehavare

See clinicaltrials.gov

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13 februari 2018

DOI

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Creative Commons BY 4.0
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Eligibility Depression NCT00956514

Engelsk

Eligibility Depression NCT00956514

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00956514
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. outpatients with non-psychotic, unipolar major depressive disorder (mdd) assessed via the mini structured interview
Beskrivning

Outpatients | Major Depressive Disorder Unipolar Without Psychotic symptom

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0443340
UMLS CUI [2,3]
C0332288
UMLS CUI [2,4]
C0871189
2. a score of ≥ 20 on the ham-d17 with item 1 (depressed mood) ≥ 2
Beskrivning

Hamilton Depression Rating Scale 17 Item Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
3. a history of treatment failure with at least one adequate trial of an antidepressant and not more than 2 trials, in the current episode, assessed by the athf
Beskrivning

Treatment failure | Antidepressive Agents | Therapeutic procedure Quantity Major depressive episode

Datatyp

boolean

Alias
UMLS CUI [1]
C0162643
UMLS CUI [2]
C0003289
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0024517
4. age range: 18-64.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. 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.
Beskrivning

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

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]
C0162425
UMLS CUI [3,3]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Informed Consent mental incapable | Informed Consent Legal incapable | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0229992
UMLS CUI [1,3]
C1550518
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1301860
UMLS CUI [2,3]
C1550518
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
2. patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); current mmse
Beskrivning

Psychotic Disorders | Psychotic Depression Lifetime | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime | Bipolar Disorder Lifetime | Dementia Lifetime | Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2,1]
C0743072
UMLS CUI [2,2]
C4071830
UMLS CUI [3,1]
C0036341
UMLS CUI [3,2]
C4071830
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]
C0451306
≤ 24; delirium or substance abuse 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 pseudodementia of depression) will be excluded.
Beskrivning

Delirium | Substance Use Disorders | Eating Disorders | Obsessive-Compulsive Disorder Lifetime | Post-Traumatic Stress Disorder | At risk for suicide | At risk of self-Injurious behavior | Uncertain diagnosis | Diagnosis Ambiguity | Rule out Pseudodementia Due to Depressive disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0011206
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0013473
UMLS CUI [4,1]
C0028768
UMLS CUI [4,2]
C4071830
UMLS CUI [5]
C0038436
UMLS CUI [6]
C0563664
UMLS CUI [7]
C3875124
UMLS CUI [8]
C1313947
UMLS CUI [9,1]
C0011900
UMLS CUI [9,2]
C2346729
UMLS CUI [10,1]
C0332196
UMLS CUI [10,2]
C0033797
UMLS CUI [10,3]
C0678226
UMLS CUI [10,4]
C0011581
3. patients with exposure to ect within the past 6 months, previous tms treatment for any condition, or vns treatment (lifetime).
Beskrivning

Exposure to Electroconvulsive Therapy | Transcranial magnetic stimulation Condition Any | Vagus Nerve Stimulation Lifetime

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013806
UMLS CUI [2,1]
C0436548
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C1552551
UMLS CUI [3,1]
C2350432
UMLS CUI [3,2]
C4071830
4. patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
5. 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 Accessing 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]
C0444454
UMLS CUI [2,3]
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
6. any history of intracranial implant; implanted cardiac pacemaker, defibrillator, vagus nerve stimulator, deep brain stimulator; or other implanted devices or objects contraindicated by product labeling.
Beskrivning

Implants Intracranial | Pacemaker implant | Defibrillators | Vagal nerve stimulator | Deep brain stimulator implant | Device implant | Medical contraindication Implants

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0524466
UMLS CUI [2]
C0848753
UMLS CUI [3]
C0180307
UMLS CUI [4]
C2959478
UMLS CUI [5]
C4069029
UMLS CUI [6]
C0948629
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0021102
7. current pregnancy, breast feeding, or not using a medically accepted means of contraception.
Beskrivning

Pregnancy | Breast Feeding | Contraceptive methods Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332268
8. other medical contraindications to any of the study procedures
Beskrivning

Medical contraindication Clinical Trial procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0184661
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Similar models

Eligibility Depression NCT00956514

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00956514
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Major Depressive Disorder Unipolar Without Psychotic symptom
Item
1. outpatients with non-psychotic, unipolar major depressive disorder (mdd) assessed via the mini structured interview
boolean
C0029921 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C0443340 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C0871189 (UMLS CUI [2,4])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
2. a score of ≥ 20 on the ham-d17 with item 1 (depressed mood) ≥ 2
boolean
C3639712 (UMLS CUI [1])
Treatment failure | Antidepressive Agents | Therapeutic procedure Quantity Major depressive episode
Item
3. a history of treatment failure with at least one adequate trial of an antidepressant and not more than 2 trials, in the current episode, assessed by the athf
boolean
C0162643 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0024517 (UMLS CUI [3,3])
Age
Item
4. age range: 18-64.
boolean
C0001779 (UMLS CUI [1])
Feeling suicidal | Self-harm Plan Absent | Self-harm Intention Absent
Item
5. 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.
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])
C0162425 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Informed Consent mental incapable | Informed Consent Legal incapable | Informed Consent Unable
Item
1. patient is mentally or legally incapacitated, unable to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0229992 (UMLS CUI [1,2])
C1550518 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C1550518 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Psychotic Disorders | Psychotic Depression Lifetime | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime | Bipolar Disorder Lifetime | Dementia Lifetime | Mini-mental state examination
Item
2. patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); current mmse
boolean
C0033975 (UMLS CUI [1])
C0743072 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C0036341 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
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])
C0451306 (UMLS CUI [7])
Delirium | Substance Use Disorders | Eating Disorders | Obsessive-Compulsive Disorder Lifetime | Post-Traumatic Stress Disorder | At risk for suicide | At risk of self-Injurious behavior | Uncertain diagnosis | Diagnosis Ambiguity | Rule out Pseudodementia Due to Depressive disorder
Item
≤ 24; delirium or substance abuse 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 pseudodementia of depression) will be excluded.
boolean
C0011206 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0013473 (UMLS CUI [3])
C0028768 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0038436 (UMLS CUI [5])
C0563664 (UMLS CUI [6])
C3875124 (UMLS CUI [7])
C1313947 (UMLS CUI [8])
C0011900 (UMLS CUI [9,1])
C2346729 (UMLS CUI [9,2])
C0332196 (UMLS CUI [10,1])
C0033797 (UMLS CUI [10,2])
C0678226 (UMLS CUI [10,3])
C0011581 (UMLS CUI [10,4])
Exposure to Electroconvulsive Therapy | Transcranial magnetic stimulation Condition Any | Vagus Nerve Stimulation Lifetime
Item
3. patients with exposure to ect within the past 6 months, previous tms treatment for any condition, or vns treatment (lifetime).
boolean
C0332157 (UMLS CUI [1,1])
C0013806 (UMLS CUI [1,2])
C0436548 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C2350432 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
Substance Use Disorders
Item
4. patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
boolean
C0038586 (UMLS CUI [1])
Skull Fracture | Cranial surgery Accessing Calvarium | Intracranial space-occupying lesion | Cerebrovascular accident | Transient Ischemic Attack | Cerebral Aneurysm | Parkinson Disease | Huntington Disease | Multiple Sclerosis
Item
5. 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])
C0444454 (UMLS CUI [2,2])
C0205950 (UMLS CUI [2,3])
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])
Implants Intracranial | Pacemaker implant | Defibrillators | Vagal nerve stimulator | Deep brain stimulator implant | Device implant | Medical contraindication Implants
Item
6. any history of intracranial implant; implanted cardiac pacemaker, defibrillator, vagus nerve stimulator, deep brain stimulator; or other implanted devices or objects contraindicated by product labeling.
boolean
C0021102 (UMLS CUI [1,1])
C0524466 (UMLS CUI [1,2])
C0848753 (UMLS CUI [2])
C0180307 (UMLS CUI [3])
C2959478 (UMLS CUI [4])
C4069029 (UMLS CUI [5])
C0948629 (UMLS CUI [6])
C1301624 (UMLS CUI [7,1])
C0021102 (UMLS CUI [7,2])
Pregnancy | Breast Feeding | Contraceptive methods Lacking
Item
7. current pregnancy, breast feeding, or not using a medically accepted means of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Medical contraindication Clinical Trial procedure
Item
8. other medical contraindications to any of the study procedures
boolean
C1301624 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
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