Eligibility Depression NCT02452892

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StudyEvent: Eligibility
1. Eligibility Depression NCT02452892

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Criteria

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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Eligibility Depression NCT02452892