Status:
COMPLETED
ANC-501 in the Treatment of Adults With Major Depressive Disorder
Lead Sponsor:
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A Phase 2 Study of ANC-501 in the treatment of adults with Major Depressive Disorder
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05439603
Start Date
September 19 2022
End Date
October 18 2023
Last Update
December 31 2024
Active Locations (8)
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1
ATP Clinical Research
Orange, California, United States, 92868
2
Florida Behavioral Medicine
Largo, Florida, United States, 33770
3
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States, 33319
4
Combined Research Orlando
Orlando, Florida, United States, 32807