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])