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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05439603
Recruitment Status : Recruiting
First Posted : June 30, 2022
Last Update Posted : February 13, 2023
Sponsor:
Information provided by (Responsible Party):
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.

Study Description
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Brief 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)

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: ANC-501 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of ANC-501 in the Treatment of Adults With Major Depressive Disorder
Actual Study Start Date : September 19, 2022
Estimated Primary Completion Date : March 25, 2023
Estimated Study Completion Date : March 25, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ANC-501
50 mg/day
 Drug: ANC-501
Five 10 mg capsules per day


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change from Baseline Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline (Day 1) to Day 56 ]
    To evaluate the effect of treatment with ANC-501 capsules on depressive symptoms in subjects with major depressive disorder (MDD)

  2. Treatment-emergent Adverse Events [ Time Frame: Baseline (Day 1) up to Day 112 ]
    Incidence and severity of adverse events, including serious adverse events and adverse events leading to study discontinuation and clinically significant changes in vital signs, physical examination endpoints, clinical safety laboratory values and ECGs


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05439603


Contacts
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Contact: Phil Perera, MD 858-504-0916 philip.perera@ancorabio.com
Contact: Lara Dennie 609-240-5896 lara.dennie@aditumbio.com

Locations
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United States, California
ATP Clinical Research Recruiting
Orange, California, United States, 92868
Contact: Gustavo Alva, MD    949-354-5353    galva@atpcr.com   
Principal Investigator: Gustavo Alva, MD         
United States, Florida
Florida Behavioral Medicine Recruiting
Largo, Florida, United States, 33770
Contact: Carlos Bussey    727-510-9773    cbussey@vantagetrials.com   
Principal Investigator: Ashok M Patel, MD         
Innovative Clinical Research, Inc. Recruiting
Lauderhill, Florida, United States, 33319
Contact: Kadian Watson    954-990-6326    kwatson@segaltrials.com   
Contact: Fedor Richani    954-990-6326    frichani@segaltrials.com   
Principal Investigator: Rishi Kakar, MD         
Combined Research Orlando Phase I-IV Recruiting
Orlando, Florida, United States, 32807
Contact: Adrian Delgado    407-440-4493    Adrian@clinicaltrialsorlando.com   
Principal Investigator: Eric Carbonell, MD         
United States, New Jersey
Clinilabs Drug Development Corporation Recruiting
Eatontown, New Jersey, United States, 07724
Contact: Amber Farwig    212-994-4567 ext 66407    afarwig@clinilabs.com   
Principal Investigator: Madgy L Shenouda, MD         
United States, New York
Richmond Behavioral Associates Recruiting
Staten Island, New York, United States, 10314
Contact: Adam D Smith, PhD    718-317-5522 ext 3    Asmith@ergclinical.com   
Principal Investigator: Mark V DiBuono, MD         
United States, Oklahoma
Conrad Clinical Research Recruiting
Edmond, Oklahoma, United States, 73013
Contact: Vicki J Conrad, M.D.    405-341-5691    vconrad@okctrials.com   
Principal Investigator: Vicki J Conrad, MD         
Sponsors and Collaborators
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
Investigators
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Study Director: Phil Perera, MD Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
More Information
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Responsible Party: Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
ClinicalTrials.gov Identifier: NCT05439603    
Other Study ID Numbers: ANC501D0005
First Posted: June 30, 2022    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms