ANC-501 in the Treatment of Adults With Major Depressive Disorder

Inclusion Criteria

• •Adult male or female between 18 and 65 years of age, inclusive.
• •Diagnosis of current episode of major depressive disorder (MDD) at least 8 weeks prior to screening, confirmed by Structured Clinical Interview for DSM-5 - Clinical Trials Version (SCID-5-CT).
• •Have not responded to their current antidepressant therapy or to dose adjustment/treatment changes following a loss of response to their current antidepressant therapy.
• •Receiving a stable dose of the same antidepressant (selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\], bupropion or trazodone monotherapy) for the current episode for at least 6 weeks of continuous treatment, which can include some or all of the screening period, with 4 weeks on a stable dose prior to day 1 and has an inadequate response (\<50% improvement) using the MGH ATRQ.
• •MADRS total score of ≥26 at screening and Day 1 (prior to dosing).
• •12-hour urine cortisol level \>22.7 nmol/L(greater than or equal to 8.3 mcg/L).