Eligibility Major Depressive Disorder NCT01082237

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StudyEvent: Eligibility
1. Eligibility Major Depressive Disorder NCT01082237

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

62 years of age or older

boolean

C0001779 (UMLS CUI [1])

Major Depressive Disorder Inventory of Depressive Symptomatology Self-Report Version Questionnaire

Item

meet the dsm-iv diagnosis of mdd based on sheehan's mini-international neuropsychiatric interview (mini), with a score of > 28 on the 30-item inventory of depressive symptomatology - self rated version (ids-sr30)

boolean

C1269683 (UMLS CUI [1,1])
C4330497 (UMLS CUI [1,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Illness Unstable Preventing Completion of clinical trial | Physical Examination | Electrocardiography | Laboratory Procedures Safety | Review of systems

Item

subjects will have no unstable medical illness that would prevent completion of participation in the trial, determined as needed from physical examination, ecg, laboratory safety tests, as well as a review of systems

boolean

C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
C0031809 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
C0022885 (UMLS CUI [4,1])
C0036043 (UMLS CUI [4,2])
C0489633 (UMLS CUI [5])

Legal capacity Lacking | Mental handicap | Informed Consent Unable

Item

mentally or legally incapacitated, unable to give informed consent

boolean

C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C1306341 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])

Item

meets dsm-iv criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major depression with psychotic features

boolean

C0003125 (UMLS CUI [1])
C2267227 (UMLS CUI [2])
C0028768 (UMLS CUI [3])
C0009241 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
C4518519 (UMLS CUI [7])

Mini-mental state examination

Item

mmse (folstein et al., 1975) score ≤ 24

boolean

C0451306 (UMLS CUI [1])

Drug Dependence | Substance Use Disorders

Item

evidence of drug dependency or substance abuse within the preceding nine months

boolean

C1510472 (UMLS CUI [1])
C0038586 (UMLS CUI [2])

Stable status | Remission | Psychotropic Drugs

Item

stable and in remission on current psychotropic medication(s)

boolean

C0205360 (UMLS CUI [1])
C0544452 (UMLS CUI [2])
C0033978 (UMLS CUI [3])

Electroconvulsive Therapy

Item

any ect within the past six months

boolean

C0013806 (UMLS CUI [1])

Intolerance to Escitalopram | Treatment failure Depressive episode | Escitalopram

Item

failure to tolerate esc or treatment failure with an adequate trial of esc in the current episode

boolean

C1744706 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C0162643 (UMLS CUI [2,1])
C0349217 (UMLS CUI [2,2])
C1099456 (UMLS CUI [3])

Medical contraindication Escitalopram | Hyponatremia Associated with Selective Serotonin Reuptake Inhibitors

Item

esc would be contraindicated (e.g., hyponatremia with a prior ssri)

boolean

C1301624 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C0020625 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0360105 (UMLS CUI [2,3])

Fluoxetine | Monoamine Oxidase Inhibitors

Item

treatment with fluoxetine or an maoi within the past four weeks

boolean

C0016365 (UMLS CUI [1])
C0026457 (UMLS CUI [2])

Illness Severe Affecting Brain function | Illness Interferes with Interpretation Research results

Item

any medical illness severe enough to significantly affect brain function or to interfere with interpretation of study results

boolean

C0221423 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0678908 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])

Seizures | Operation on brain | Skull Fractures | Craniocerebral Trauma | Electroencephalogram abnormal

Item

history of seizures, brain surgery, skull fracture, significant head trauma, or abnormal eeg

boolean

C0036572 (UMLS CUI [1])
C0195775 (UMLS CUI [2])
C0037304 (UMLS CUI [3])
C0018674 (UMLS CUI [4])
C0151611 (UMLS CUI [5])

Indication Psychiatric hospitalization | DANGER OF HARM TO SELF | At risk of harming others

Item

psychiatric hospitalization indicated (e.g., imminent danger to self or others)

boolean

C3146298 (UMLS CUI [1,1])
C0748061 (UMLS CUI [1,2])
C0149660 (UMLS CUI [2])
C1271966 (UMLS CUI [3])

Electroencephalography Quantitative Unsuccessful | Biomarkers Determination Excluded

Item

initial qeeg recording is contaminated with artifact so that determination of the biomarker is precluded

boolean

C0013819 (UMLS CUI [1,1])
C0392762 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0005516 (UMLS CUI [2,1])
C0521095 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])

Item

use of medications known to affect brain function (e.g., antidepressants, anticonvulsants/mood stabilizers, anticholinergics, antipsychotics, benzodiazepines -

boolean

C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678908 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
C2917435 (UMLS CUI [4])
C0242896 (UMLS CUI [5])
C0040615 (UMLS CUI [6])
C0005064 (UMLS CUI [7])

Other Coding

Item

same list as in brite-md)

boolean

C3846158 (UMLS CUI [1])

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Eligibility Major Depressive Disorder NCT01082237