ANC-501 in the Treatment of Adults With Major Depressive Disorder
NCT ID: NCT05439603
Last Updated: 2024-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2022-09-19
2023-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ANC-501
50 mg/day
ANC-501
Five 10 mg capsules per day
Interventions
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ANC-501
Five 10 mg capsules per day
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Phil Perera, MD
Role: STUDY_DIRECTOR
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ANC501D0005
Identifier Type: -
Identifier Source: org_study_id