DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Unipolar | Informed Consent
Item
outpatients with non-psychotic, unipolar major depressive disorder assessed via the mini structured interview and legally capacitated to sign the informed consent for participation in the study;
boolean
C0743081 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Depressed mood
Item
a score of ≥ 14 on the ham-d17 with item 1 (depressed mood) ≥ 2;
boolean
C3639712 (UMLS CUI [1])
C0344315 (UMLS CUI [2])
Treatment failure | Antidepressive Agents Quantity | Pharmaceutical Preparations Quantity | Antidepressive Agents Unchanged | Dosage Unchanged
Item
a history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study);
boolean
C0162643 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003289 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])
C0178602 (UMLS CUI [5,1])
C0442739 (UMLS CUI [5,2])
Feeling suicidal | Self-harm Plan Absent | Self-harm Intention Absent | Self-harm Attempt Lacking
Item
patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm and lack of self-harming attempt in the past 6 months;
boolean
C0424000 (UMLS CUI [1])
C0424366 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0424366 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0424366 (UMLS CUI [4,1])
C1516084 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
Protocol Compliance
Item
patients with appropriate support to be compliant with the study protocol.
boolean
C0525058 (UMLS CUI [1])
Mental impairment | Legal capacity Lacking | Informed Consent Unable
Item
patient is mentally or legally incapacitated, unable to give informed consent.
boolean
C0683322 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Psychotic Disorders | Depression, psychotic | Schizophrenia | Schizoaffective Disorder Lifetime | Bipolar Disorder Lifetime | Dementia Lifetime | Delirium | Substance Use Disorders | Eating Disorders | Obsessive-Compulsive Disorder Lifetime | Post-Traumatic Stress Disorder | At risk for suicide | At risk of self-injurious behavior | Uncertainty Diagnostic | Ambiguity Diagnostic
Item
patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded.
boolean
C0033975 (UMLS CUI [1])
C0743072 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0005586 (UMLS CUI [5,1])
C4071830 (UMLS CUI [5,2])
C0497327 (UMLS CUI [6,1])
C4071830 (UMLS CUI [6,2])
C0011206 (UMLS CUI [7])
C0038586 (UMLS CUI [8])
C0013473 (UMLS CUI [9])
C0028768 (UMLS CUI [10,1])
C4071830 (UMLS CUI [10,2])
C0038436 (UMLS CUI [11])
C0563664 (UMLS CUI [12])
C3875124 (UMLS CUI [13])
C0087130 (UMLS CUI [14,1])
C0348026 (UMLS CUI [14,2])
C2346729 (UMLS CUI [15,1])
C0348026 (UMLS CUI [15,2])
Pharmaceutical Preparations Quantity Major Depressive Disorder
Item
patients currently receiving more than six medications for treatment of mdd;
boolean
C0013227 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1269683 (UMLS CUI [1,3])
Exposure to Electroconvulsive Therapy | Exposure to Repetitive Transcranial Magnetic Stimulation | Exposure to Investigational Therapy
Item
patients with exposure to ect or rtms or any investigational treatment (for any disorder) within the past 6 months;
boolean
C0332157 (UMLS CUI [1,1])
C0013806 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0872259 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0949266 (UMLS CUI [3,2])
Vagus Nerve Stimulation Lifetime | Deep Brain Stimulation Lifetime
Item
prior vns and/or dbs therapy (lifetime);
boolean
C2350432 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0394162 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
Skull Fracture | Cranial surgery Calvarium | Intracranial space-occupying lesion | Cerebrovascular accident | Transient Ischemic Attack | Cerebral Aneurysm | Parkinson Disease | Huntington Disease | Multiple Sclerosis
Item
past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, cva, or tias; cerebral aneurysm; parkinson's or huntington's disease; or multiple sclerosis;
boolean
C0037304 (UMLS CUI [1])
C2224798 (UMLS CUI [2,1])
C0205950 (UMLS CUI [2,2])
C0495785 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0917996 (UMLS CUI [6])
C0030567 (UMLS CUI [7])
C0020179 (UMLS CUI [8])
C0026769 (UMLS CUI [9])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
current pregnancy, breast feeding, plans to become pregnant during the study, or not using a medically accepted means of contraception;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Other medical condition At risk Communicable Disease | Morbidity Surgical Related | Other medical condition Affecting Protocol Compliance
Item
other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0220880 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])