Major Depressive Disorder
Item
1. dsm-5 diagnosis of a major depressive disorder based on clinical evaluation by the study psychiatrist
boolean
C1269683 (UMLS CUI [1])
Moderate depression Montgomery-Asberg Depression Rating Scale Questionnaire | Severe depression Montgomery-Asberg Depression Rating Scale Questionnaire
Item
2. at least moderate severity of depression as indicated by a montgomery-asberg depression rating scale (madrs) score of 22 or greater
boolean
C0588007 (UMLS CUI [1,1])
C4054475 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2,1])
C4054475 (UMLS CUI [2,2])
Coronary Artery Disease
Item
3. history of coronary artery disease as defined by:
boolean
C1956346 (UMLS CUI [1])
Coronary Stenosis Percentage Vessel Quantity | Coronary angiography | CT Angiography
Item
history of coronary stenosis in one or more vessels that is greater ≥ 70% by coronary angiography or ct angiogram, or
boolean
C0242231 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0085532 (UMLS CUI [2])
C1536105 (UMLS CUI [3])
Cardiac stress test abnormal | Defect Moderate | Defect Reversible
Item
history of abnormal stress test (at least medium-sized, moderate, reversible defect), or
boolean
C1096350 (UMLS CUI [1])
C1457869 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C1457869 (UMLS CUI [3,1])
C0205343 (UMLS CUI [3,2])
Myocardial Infarction | ST segment elevation myocardial infarction | Non-ST elevation (NSTEMI) myocardial infarction | Troponin increased
Item
history of documented myocardial infarction including st elevation myocardial infarction or non-st elevation myocardial infarction (with elevated troponins), or
boolean
C0027051 (UMLS CUI [1])
C1536220 (UMLS CUI [2])
C1561921 (UMLS CUI [3])
C1141948 (UMLS CUI [4])
Therapeutic procedure Adequate Coronary Artery Disease
Item
4. evidence of adequate treatment of the coronary artery disease as defined by at least one of the following that was done at least six months prior to the screening visit, and was followed by the patient being clinically stable in the opinion of a cardiologist who has evaluated the case:
boolean
C0087111 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C1956346 (UMLS CUI [1,3])
Coronary Artery Bypass Surgery
Item
coronary artery bypass grafting (cabg)
boolean
C0010055 (UMLS CUI [1])
Percutaneous Coronary Intervention | Stenting
Item
percutaneous coronary intervention (pci)/ stenting
boolean
C1532338 (UMLS CUI [1])
C2348535 (UMLS CUI [2])
Therapeutic procedure Optimal | Aspirin | Adrenergic beta-1 Receptor Antagonists | Statin | atorvastatin | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
adequate management with optimal medical treatment (such as one or more of the following medications: aspirin, beta blockers, a statin (e.g., atorvastatin), and either an ace inhibitor or an angiotensin-receptor blocker.)
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0004057 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
C0360714 (UMLS CUI [4])
C0286651 (UMLS CUI [5])
C0003015 (UMLS CUI [6])
C0521942 (UMLS CUI [7])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Exclusion Criteria Psychiatric
Item
psychiatric exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
Therapy non-responder | Vortioxetine U/day | Adverse effects Unacceptable Vortioxetine
Item
1. patients who in the past have failed to respond to a trial of vortioxetine at the minimum recommended dose (10 mg/day) or greater taken for at least six weeks, or had unacceptable adverse effects while taking vortioxetine.
boolean
C0919875 (UMLS CUI [1])
C3661282 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0879626 (UMLS CUI [3,1])
C1883420 (UMLS CUI [3,2])
C3661282 (UMLS CUI [3,3])
Antidepressive Agents Quantity Major depressive episode
Item
2. patients must not have failed treatment with more than one antidepressant (taken at an adequate dose and for at least six weeks) in the current episode of major depressive disorder (i.e., did not have > 50% reduction in severity of depression based on patient history)
boolean
C0003289 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0024517 (UMLS CUI [1,3])
Principal diagnosis
Item
3. patients with a current primary dsm-5 diagnosis of:
boolean
C0332137 (UMLS CUI [1])
Delirium | Dementia | Amnestic Disorder | Cognition Disorders | Eating Disorders | Anorexia Nervosa | Bulimia | Obsessive-Compulsive Disorder | Panic Disorder | Post-Traumatic Stress Disorder
Item
i) delirium, dementia, amnestic, or other cognitive disorder; ii) eating disorder (including anorexia nervosa or bulimia); iii) obsessive compulsive disorder; iv) panic disorder; v) post-traumatic stress disorder (ptsd);
boolean
C0011206 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0002625 (UMLS CUI [3])
C0009241 (UMLS CUI [4])
C0013473 (UMLS CUI [5])
C0003125 (UMLS CUI [6])
C0006370 (UMLS CUI [7])
C0028768 (UMLS CUI [8])
C0030319 (UMLS CUI [9])
C0038436 (UMLS CUI [10])
Diagnosis | Diagnosis Lifetime
Item
4. current or past (lifetime) dsm-5 diagnosis of:
boolean
C0011900 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
Bipolar I disorder | Bipolar II disorder | Hypomanic episode | Manic episode Drug-induced | Hypomanic episode Drug-induced | Schizophrenia | Psychotic Disorders
Item
i) bipolar i or ii disorder; ii) hypomanic episode iii) substance-induced manic or hypomanic episode iii) schizophrenia or other psychotic disorder
boolean
C0853193 (UMLS CUI [1])
C0236788 (UMLS CUI [2])
C1396834 (UMLS CUI [3])
C0349208 (UMLS CUI [4,1])
C0458082 (UMLS CUI [4,2])
C1396834 (UMLS CUI [5,1])
C0458082 (UMLS CUI [5,2])
C0036341 (UMLS CUI [6])
C0033975 (UMLS CUI [7])
Exclusion Criteria Cardiovascular
Item
cardiovascular exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
Myocardial Infarction
Item
1. patients who have had a myocardial infarction within 30 days of the screening visit
boolean
C0027051 (UMLS CUI [1])
Cardiovascular Disease Unstable | Cardiovascular Disease Decompensated
Item
2. any cardiovascular condition that is unstable or decompensated
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205434 (UMLS CUI [2,2])
At risk Adverse event Cardiovascular
Item
3. in the opinion of the investigators, the patient is at significant risk of cardiovascular adverse events
boolean
C1444641 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3887460 (UMLS CUI [1,3])
Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
4. coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci)/
boolean
C0010055 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
Stenting
Item
stenting within three months of the screening visit
boolean
C2348535 (UMLS CUI [1])
Hospital admission Due to Heart Disease
Item
5. admission to a hospital for any cardiac condition within three months of the screening visit
boolean
C0184666 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,3])
Decompensated cardiac failure
Item
6. decompensated heart failure within 6 months of the screening visit
boolean
C0581377 (UMLS CUI [1])
Prolonged QTc interval Fridericia formula | Gender
Item
7. qtc prolongation (screening ecg with qtc ≥ 450 msec for men or qtc ≥ 470 msec for women) using qtc fridericia correction
boolean
C1560305 (UMLS CUI [1,1])
C4037934 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
Second degree atrioventricular block | Mobitz type II atrioventricular block | Complete atrioventricular block
Item
8. second-degree (if mobitz ii) or third-degree atrioventricular block
boolean
C0264906 (UMLS CUI [1])
C0155700 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
Heart rate Electrocardiography | Heart rate Symptomatic
Item
9. heart rate on ecg of ≤ 50 bpm or ≥ 120 bpm or any heart rate that is clinically symptomatic
boolean
C0018810 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Premature ventricular contractions Associated with Symptoms Clinical | Premature ventricular contractions Complex | Premature ventricular contractions Frequent | Premature ventricular contractions Multifocal | Premature ventricular contractions Bigeminy | Premature ventricular contractions Trigeminy | Premature ventricular contractions Quadrigeminy | Premature ventricular contractions Couplets | Premature ventricular contractions, including couplets and triplets | Other Coding | R on T phenomenon
Item
10. premature ventricular contractions (pvcs) associated with clinical symptoms and/or any complex premature ventricular contractions (ie, pvcs that are frequent [> 30/hr] or ≥ 2 beats if multifocal, or show bigeminy, trigeminy, quadrigeminy, couplets, triplets [salvos], or the r on t phenomenon)
boolean
C0151636 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
C0151636 (UMLS CUI [2,1])
C0439855 (UMLS CUI [2,2])
C0151636 (UMLS CUI [3,1])
C0332183 (UMLS CUI [3,2])
C0151636 (UMLS CUI [4,1])
C0205292 (UMLS CUI [4,2])
C0151636 (UMLS CUI [5,1])
C3714585 (UMLS CUI [5,2])
C0151636 (UMLS CUI [6,1])
C0232119 (UMLS CUI [6,2])
C0151636 (UMLS CUI [7,1])
C0429000 (UMLS CUI [7,2])
C0151636 (UMLS CUI [8,1])
C0429001 (UMLS CUI [8,2])
C3554050 (UMLS CUI [9])
C3846158 (UMLS CUI [10])
C0877658 (UMLS CUI [11])
Atrial Fibrillation | Atrial Flutter
Item
11. atrial fibrillation or flutter
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
Lying systolic blood pressure | Lying diastolic blood pressure | Systolic Pressure Symptomatic | Diastolic blood pressure Symptomatic
Item
12. supine (after patient has been supine for 5 minutes) systolic bp > 160 mm hg or < 90 mm hg or diastolic bp > 100 mm hg or any systolic or diastolic bp that is symptomatic or clinically significant based on the opinion of the principal investigator
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0428883 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Warfarin
Item
13. patients who are receiving warfarin
boolean
C0043031 (UMLS CUI [1])