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

• Status: Not yet recruiting
• Trial end date: 2023-03-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, open-label Phase 2 study to assess the safety, tolerability, pharmacokinetics (PK), and activity of ANC-501 oral capsules as adjunctive treatment in subjects diagnosed with major depressive disorder (MDD)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ancora Bio, Inc.

Criteria

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.