Major Depressive Disorder | Major Depressive Disorder Recurrent | Major depressive episode In the past
Item
participants with a current/recurrent or past episode of major depressive disorder (mdd) as established per mini international neuropsychiatric interview at screening or otherwise specified by the treating physician
boolean
C1269683 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0024517 (UMLS CUI [3,1])
C1444637 (UMLS CUI [3,2])
Selective Serotonin Reuptake Inhibitors Stable
Item
stably treated with selective serotonin re-uptake inhibitor /
boolean
C0360105 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) Dose unchanged
Item
serotonin-norepinephrine reuptake inhibitor monotherapy, with no change in dose in the last 30 days before screening
boolean
C1579361 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Sleeplessness Polysomnography
Item
insomnia per polysomnography (a diagnostic test to measure and record physiologic variables like latency to persistent sleep, total sleep time, sleep efficiency, time spent awake, and total time spent in deep sleep, during sleep)
boolean
C0917801 (UMLS CUI [1,1])
C0162701 (UMLS CUI [1,2])
Healthy Volunteers Laboratory Procedures | Stable status Medical Laboratory Procedures
Item
participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening
boolean
C1708335 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0205360 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
Gender Childbearing Potential Absent | Tubal Ligation | Hysterectomy | Postmenopausal state | Menses Spontaneous Absent
Item
female participants should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years)
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0520483 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C0025344 (UMLS CUI [5,1])
C0205359 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Psychotic Disorder | Major Depressive Disorder with Psychotic Disorder | Bipolar Disorder | Mental Retardation | Personality Disorders | Borderline Personality Disorder | Antisocial Personality Disorder
Item
has a current diagnosis of a psychotic disorder, mdd with psychosis, bipolar disorder, mental retardation, or cluster b personality disorder (eg, borderline personality disorders, antisocial personality disorder)
boolean
C0033975 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0033975 (UMLS CUI [2,3])
C0005586 (UMLS CUI [3])
C0025362 (UMLS CUI [4])
C0031212 (UMLS CUI [5])
C0006012 (UMLS CUI [6])
C0003431 (UMLS CUI [7])
Abnormal breathing Sleep Related
Item
has been diagnosed with sleep-related breathing disorder
boolean
C1260922 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Feeling suicidal | Suicidal intent | Homicidal thoughts | Homicidal intent
Item
has suicidal ideation with some intent to act, or has homicidal ideation/intent, per principal investigator's clinical judgment
boolean
C0424000 (UMLS CUI [1])
C0582496 (UMLS CUI [2])
C0455204 (UMLS CUI [3])
C2046965 (UMLS CUI [4])
Abnormal circadian rhythm | Night shift worker | Bedtime Post Midnight
Item
abnormal day/night rhythm, eg, nightshift worker, or normal bed time past midnight
boolean
C0231316 (UMLS CUI [1])
C0555008 (UMLS CUI [2])
C0521112 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0332172 (UMLS CUI [3,3])
Uncontrolled hypertension | Hypertensive crisis
Item
has uncontrolled hypertension at screening and day 1 prior to randomization; or any past history of hypertensive crisis
boolean
C1868885 (UMLS CUI [1])
C0020546 (UMLS CUI [2])