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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 : December 8, 2022
Sponsor:
Information provided by (Responsible Party):
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.

Tracking Information
First Submitted Date  ICMJE June 21, 2022
First Posted Date  ICMJE June 30, 2022
Last Update Posted Date December 8, 2022
Actual Study Start Date  ICMJE September 19, 2022
Estimated Primary Completion Date March 25, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2022)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ANC-501 in the Treatment of Adults With Major Depressive Disorder
Official Title  ICMJE A Phase 2 Study of ANC-501 in the Treatment of Adults With Major Depressive Disorder
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: ANC-501
Five 10 mg capsules per day
Study Arms  ICMJE Experimental: ANC-501
50 mg/day
Intervention: Drug: ANC-501
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2022)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 25, 2023
Estimated Primary Completion Date March 25, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Phil Perera, MD 858-504-0916 philip.perera@ancorabio.com
Contact: Lara Dennie 609-240-5896 lara.dennie@aditumbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05439603
Other Study ID Numbers  ICMJE ANC501D0005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Phil Perera, MD Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
PRS Account Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP