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

This is an interventional treatment trial for Major Depressive Disorder Read More

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] monotherapy) for the current episode for at least 8 weeks of continuous treatment with 4 weeks being on a stable dose prior to Day 1 and has an inadequate response (<50% improvement) using the MGH ATRQ.
• MADRS total score of ≥28 at screening and Day 1 (prior to dosing).
• Elevation of cortisol as measured by 12-hour urine collection.

Exclusion Criteria:

• Inadequate response to >2 prior ADTs (not including current antidepressant) of at least 6 weeks duration each for the episode current at screening.
• Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
• Administration of drugs to treat a psychiatric or neurologic condition that have been initiated within 8 weeks prior to screening and/or are not being taken at a stable dose (current dose must be stable for 4 weeks preceding screening).
• Significant findings on ophthalmic examination including, Best Corrected Visual Acuity (BCVA) worse than 20/30 or, in the opinion of the ophthalmologist, any cataract that may become clinically significant and/or need surgical intervention during the course of the trial.