Major Depressive Disorder
Item
participants must have a primary dsm-5 diagnosis of mdd
boolean
C1269683 (UMLS CUI [1])
Hamilton rating scale for depression
Item
must have a hdrs total score greater than or equal to (>=) 18 at screening and predose at day 1, as recorded by the remote independent rater and must not demonstrate an improvement of >= 20 percent (%) on their hdrs total score from the screening to baseline visit
boolean
C0451203 (UMLS CUI [1])
hsCRP
Item
must have a hscrp >=0.300 milligram per deciliters (mg/dl) (si 3.00 mg/l) at screening
boolean
C0973334 (UMLS CUI [1])
Stable status Medical Physical Examination | Stable status Medical Medical History | Stable status Medical Vital signs | Stable status Medical Laboratory Procedures | Stable status Medical 12 lead ECG
Item
must be medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests and 12-lead ecg performed at screening. if there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. this determination must be recorded in the subject's source documents and initialed by the investigator
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0205360 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C0205360 (UMLS CUI [3,1])
C0205476 (UMLS CUI [3,2])
C0150404 (UMLS CUI [3,3])
C0205360 (UMLS CUI [4,1])
C0205476 (UMLS CUI [4,2])
C0022885 (UMLS CUI [4,3])
C0205360 (UMLS CUI [5,1])
C0205476 (UMLS CUI [5,2])
C0430456 (UMLS CUI [5,3])
Therapeutic procedure Stable Hypothyroidism | Requirement Thyrotropin | Requirement Free thyroxin | Thyroid stimulating hormone measurement | T4 free measurement
Item
participants with hypothyroidism who are on stable treatment for 3 months prior to screening are required to have thyroid stimulating hormone (tsh) and free thyroxine (ft4) obtained. if the tsh value is out of range, but ft4 is normal, such cases should be discussed directly with the medical monitor before the subject is enrolled. if the ft4 value is out of range, the participant is not eligible
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0020676 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0040160 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0312452 (UMLS CUI [3,2])
C0202230 (UMLS CUI [4])
C0202225 (UMLS CUI [5])
Axis I diagnosis | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE | Bipolar Disorder | Bipolar Disorder Lifetime | Obsessive-Compulsive Disorder | Borderline Personality Disorder | Eating Disorders | Bulimia | Anorexia Nervosa | Schizophrenia Lifetime | Generalized Anxiety Disorder Comorbid allowed | Post-Traumatic Stress Disorder Comorbid allowed | Social Phobia Comorbid allowed | Panic Disorder Comorbid allowed | Nicotine Dependence Comorbid allowed | Caffeine dependence Comorbid allowed
Item
any other current axis one psychiatric condition, including, but not limited to, mdd with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (eg, bulimia, anorexia nervosa), or schizophrenia (lifetime). the mini will be used to screen for comorbid psychiatric diagnoses. as noted above, subjects with a diagnosis of comorbid gad, post-traumatic stress disorder, social anxiety disorder, panic disorder or nicotine/caffeine dependence may be included, if the investigator considers mdd to be the primary diagnosis
boolean
C0270287 (UMLS CUI [1])
C0743080 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0005586 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0028768 (UMLS CUI [5])
C0006012 (UMLS CUI [6])
C0013473 (UMLS CUI [7])
C0006370 (UMLS CUI [8])
C0003125 (UMLS CUI [9])
C0036341 (UMLS CUI [10,1])
C4071830 (UMLS CUI [10,2])
C0270549 (UMLS CUI [11,1])
C1275743 (UMLS CUI [11,2])
C0683607 (UMLS CUI [11,3])
C0038436 (UMLS CUI [12,1])
C1275743 (UMLS CUI [12,2])
C0683607 (UMLS CUI [12,3])
C0031572 (UMLS CUI [13,1])
C1275743 (UMLS CUI [13,2])
C0683607 (UMLS CUI [13,3])
C0030319 (UMLS CUI [14,1])
C1275743 (UMLS CUI [14,2])
C0683607 (UMLS CUI [14,3])
C0028043 (UMLS CUI [15,1])
C1275743 (UMLS CUI [15,2])
C0683607 (UMLS CUI [15,3])
C1386553 (UMLS CUI [16,1])
C1275743 (UMLS CUI [16,2])
C0683607 (UMLS CUI [16,3])
Substance Use Disorders | Substance Dependence
Item
a history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Feeling suicidal Score | Suicidal behavior Columbia suicide severity rating scale
Item
a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the c-ssrs at screening or baseline. subjects with a prior suicide attempt of any sort, or history of prior serious suicidal ideation/plan should be carefully screened for current suicidal ideation and only included at the discretion of the investigator
boolean
C0424000 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C1760428 (UMLS CUI [2,1])
C3888485 (UMLS CUI [2,2])
Antidepressant therapy Quantity failed | Antidepressant therapy Dosage Duration | Episode of Depressive disorder | Response to antidepressant Questionnaires
Item
more than 3 failed antidepressant treatments (of adequate dose and duration) in the current episode of depression (verified by the mgh-atrq)
boolean
C1096649 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1096649 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0332189 (UMLS CUI [3,1])
C0011581 (UMLS CUI [3,2])
C3549249 (UMLS CUI [4,1])
C0034394 (UMLS CUI [4,2])
Major depressive episode Duration
Item
length of current major depressive episode > 24 months
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])