ID

35704

Description

Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD); ODM derived from: https://clinicaltrials.gov/show/NCT02452892

Link

https://clinicaltrials.gov/show/NCT02452892

Keywords

Versions (1)
  1. 3/16/19 3/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT02452892

English

Eligibility Depression NCT02452892

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02452892
Criteria
Description

Criteria

meets the diagnostic and statistical manual of mental disorder, 5th edition (dsm-5) criteria for major depressive disorder (mdd), as determined by psychiatric evaluation.
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
has trd of the current mde, as assessed at the site by the massachusetts general hospital/antidepressant treatment response questionnaire (mgh/atrq).
Description

Treatment-Resistant Depressive Disorder | Major depressive episode | Response to antidepressant Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C2063866
UMLS CUI [2]
C0024517
UMLS CUI [3,1]
C3549249
UMLS CUI [3,2]
C0034394
on an adequate dose of one antidepressant therapy (adt) for at least eight weeks prior to the screening visit (visit 1). the adt dose must be stable for at least four weeks prior to the screening visit (visit 1). subjects must be willing to remain on the same stable dose of adt upon signing the informed consent form until the end of the treatment observation period (end of week 2) and, where possible, to the end of study participation
Description

Antidepressant therapy Dose Stable | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0021430
exclusion criteria: (key)
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
have failed four or more lifetime adequate adt treatment regimens (including the ongoing adt for the current mde).
Description

Antidepressant therapy Quantity failed

Data type

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
have been treated with adjunctive antipsychotic medication with an antidepressant for at least two weeks during the current depressive episode.
Description

Antipsychotic Agents adjunctive | Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C3858690
UMLS CUI [2]
C0003289
are deemed to be at significant risk for suicidal behavior
Description

At risk Suicidal behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C1760428
are unable to lie on their back for the duration of study treatment
Description

Lacking Able to lie down Supine Position

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560841
UMLS CUI [1,3]
C0038846
have a lifetime history of:
Description

Medical History Lifetime

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C4071830
1. delirium, dementia, amnestic, or other cognitive disorder;
Description

Delirium | Dementia | Amnestic Disorder | Cognition Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0011206
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0002625
UMLS CUI [4]
C0009241
2. schizophrenia or any psychotic disorder, based on the structured clinical interview for dsm-5 axis i disorders patient edition (scid-i/p);
Description

Schizophrenia | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0033975
3. bipolar i or ii disorder, based on the scid-i/p.
Description

Bipolar I disorder | Bipolar II disorder

Data type

boolean

Alias
UMLS CUI [1]
C0853193
UMLS CUI [2]
C0236788
have a current dsm-5 diagnosis at the screening visit (visit 1) of:
Description

DSM-V Diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1137105
UMLS CUI [1,2]
C0011900
1. an eating disorder active within the 12 months prior to the screening visit (visit 1);
Description

Eating Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0013473
2. comorbid anxiety disorders that predominate over mdd, as assessed by the investigator;
Description

Anxiety Disorders Predominating Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0003469
UMLS CUI [1,2]
C0332251
UMLS CUI [1,3]
C1269683
3. alcohol or substance use disorder active within the 12 months prior to the screening visit (visit 1);
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
4. clinically significant dsm-5 axis ii disorder.
Description

Axis II diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0270288
have ever received electroconvulsive therapy, vagal nerve stimulation, deep brain stimulation or repetitive transcranial magnetic stimulation.
Description

Electroconvulsive Therapy | Vagus Nerve Stimulation | Deep Brain Stimulation | Transcranial Magnetic Stimulation, Repetitive

Data type

boolean

Alias
UMLS CUI [1]
C0013806
UMLS CUI [2]
C2350432
UMLS CUI [3]
C0394162
UMLS CUI [4]
C0872259
have a non-removable programmable device or appliance such as cardiac pacemakers or cochlear implants.
Description

Artificial cardiac pacemaker | Cochlear Implants

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0009199
have any non-removable ferromagnetic implants, or conductive or other magnetic sensitive materials present in the head or neck .
Description

Implants magnetic | Materials magnetic Head | Materials magnetic Neck

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0563532
UMLS CUI [2,1]
C0520510
UMLS CUI [2,2]
C0563532
UMLS CUI [2,3]
C0018670
UMLS CUI [3,1]
C0520510
UMLS CUI [3,2]
C0563532
UMLS CUI [3,3]
C0027530
have a lifetime history of seizures or clinically significant electroencephalography abnormalities. a history of childhood febrile seizures is permitted.
Description

Medical History Lifetime Seizures | Electroencephalography Abnormality | Febrile seizures in early childhood allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C4071830
UMLS CUI [1,3]
C0036572
UMLS CUI [2,1]
C0013819
UMLS CUI [2,2]
C1704258
UMLS CUI [3,1]
C0009952
UMLS CUI [3,2]
C0683607
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Similar models

Eligibility Depression NCT02452892

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02452892
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Major Depressive Disorder
Item
meets the diagnostic and statistical manual of mental disorder, 5th edition (dsm-5) criteria for major depressive disorder (mdd), as determined by psychiatric evaluation.
boolean
C1269683 (UMLS CUI [1])
Treatment-Resistant Depressive Disorder | Major depressive episode | Response to antidepressant Questionnaire
Item
has trd of the current mde, as assessed at the site by the massachusetts general hospital/antidepressant treatment response questionnaire (mgh/atrq).
boolean
C2063866 (UMLS CUI [1])
C0024517 (UMLS CUI [2])
C3549249 (UMLS CUI [3,1])
C0034394 (UMLS CUI [3,2])
Antidepressant therapy Dose Stable | Informed Consent
Item
on an adequate dose of one antidepressant therapy (adt) for at least eight weeks prior to the screening visit (visit 1). the adt dose must be stable for at least four weeks prior to the screening visit (visit 1). subjects must be willing to remain on the same stable dose of adt upon signing the informed consent form until the end of the treatment observation period (end of week 2) and, where possible, to the end of study participation
boolean
C1096649 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2])
Exclusion Criteria Main
Item
exclusion criteria: (key)
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Antidepressant therapy Quantity failed
Item
have failed four or more lifetime adequate adt treatment regimens (including the ongoing adt for the current mde).
boolean
C1096649 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Antipsychotic Agents adjunctive | Antidepressive Agents
Item
have been treated with adjunctive antipsychotic medication with an antidepressant for at least two weeks during the current depressive episode.
boolean
C0040615 (UMLS CUI [1,1])
C3858690 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2])
At risk Suicidal behavior
Item
are deemed to be at significant risk for suicidal behavior
boolean
C1444641 (UMLS CUI [1,1])
C1760428 (UMLS CUI [1,2])
Lacking Able to lie down Supine Position
Item
are unable to lie on their back for the duration of study treatment
boolean
C0332268 (UMLS CUI [1,1])
C0560841 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
Medical History Lifetime
Item
have a lifetime history of:
boolean
C0262926 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
Delirium | Dementia | Amnestic Disorder | Cognition Disorders
Item
1. delirium, dementia, amnestic, or other cognitive disorder;
boolean
C0011206 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0002625 (UMLS CUI [3])
C0009241 (UMLS CUI [4])
Schizophrenia | Psychotic Disorders
Item
2. schizophrenia or any psychotic disorder, based on the structured clinical interview for dsm-5 axis i disorders patient edition (scid-i/p);
boolean
C0036341 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
Bipolar I disorder | Bipolar II disorder
Item
3. bipolar i or ii disorder, based on the scid-i/p.
boolean
C0853193 (UMLS CUI [1])
C0236788 (UMLS CUI [2])
DSM-V Diagnosis
Item
have a current dsm-5 diagnosis at the screening visit (visit 1) of:
boolean
C1137105 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Eating Disorder
Item
1. an eating disorder active within the 12 months prior to the screening visit (visit 1);
boolean
C0013473 (UMLS CUI [1])
Anxiety Disorders Predominating Major Depressive Disorder
Item
2. comorbid anxiety disorders that predominate over mdd, as assessed by the investigator;
boolean
C0003469 (UMLS CUI [1,1])
C0332251 (UMLS CUI [1,2])
C1269683 (UMLS CUI [1,3])
Substance Use Disorders
Item
3. alcohol or substance use disorder active within the 12 months prior to the screening visit (visit 1);
boolean
C0038586 (UMLS CUI [1])
Axis II diagnosis
Item
4. clinically significant dsm-5 axis ii disorder.
boolean
C0270288 (UMLS CUI [1])
Electroconvulsive Therapy | Vagus Nerve Stimulation | Deep Brain Stimulation | Transcranial Magnetic Stimulation, Repetitive
Item
have ever received electroconvulsive therapy, vagal nerve stimulation, deep brain stimulation or repetitive transcranial magnetic stimulation.
boolean
C0013806 (UMLS CUI [1])
C2350432 (UMLS CUI [2])
C0394162 (UMLS CUI [3])
C0872259 (UMLS CUI [4])
Artificial cardiac pacemaker | Cochlear Implants
Item
have a non-removable programmable device or appliance such as cardiac pacemakers or cochlear implants.
boolean
C0030163 (UMLS CUI [1])
C0009199 (UMLS CUI [2])
Implants magnetic | Materials magnetic Head | Materials magnetic Neck
Item
have any non-removable ferromagnetic implants, or conductive or other magnetic sensitive materials present in the head or neck .
boolean
C0021102 (UMLS CUI [1,1])
C0563532 (UMLS CUI [1,2])
C0520510 (UMLS CUI [2,1])
C0563532 (UMLS CUI [2,2])
C0018670 (UMLS CUI [2,3])
C0520510 (UMLS CUI [3,1])
C0563532 (UMLS CUI [3,2])
C0027530 (UMLS CUI [3,3])
Medical History Lifetime Seizures | Electroencephalography Abnormality | Febrile seizures in early childhood allowed
Item
have a lifetime history of seizures or clinically significant electroencephalography abnormalities. a history of childhood febrile seizures is permitted.
boolean
C0262926 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0036572 (UMLS CUI [1,3])
C0013819 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0009952 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
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