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

Completed · Phase 2

Conditions studied: Major Depressive Disorder

In brief

A Phase 2 Study of ANC-501 in the treatment of adults with Major Depressive Disorder

Key facts

Study ID

NCT05439603

Run by

Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.

People needed

15

Starts

2022-09-19

Expected to finish

2023-10-18

Last updated by the study team

2024-12-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 psychiatric or neurologic conditions that have not been taken at a stable dose for at least 4 weeks prior to day 1.
• Significant findings on ophthalmic examination including, Best Corrected Visual Acuity (BCVA) worse than 20/30 or, in the opinion of the ophthalmologist or optometrist, any cataract that may become clinically significant and/or need surgical intervention during the course of the trial.

Where it is running

• ATP Clinical Research — Orange, California, United States
• Florida Behavioral Medicine — Largo, Florida, United States
• Innovative Clinical Research, Inc. — Lauderhill, Florida, United States
• Combined Research Orlando — Orlando, Florida, United States
• Clinilabs Drug Development Corporation — Eatontown, New Jersey, United States
• Clinilabs Drug development Corporation — New York, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• Conrad Clinical Research — Edmond, Oklahoma, United States

Full record on ClinicalTrials.gov

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