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

NCT05439603 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ANC501D0005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.

  The MADRS was utilized as the primary efficacy assessment of the participant's level of depression. The MADRS consists of 10 items, all rated on a scale 0 to 6 with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.

  Baseline (Day 1) to Day 56

Secondary Outcomes (7)

• Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints.

  Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70

• Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response.

  Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70

• Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission.

  Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70

• Mean Change From Baseline (Day 1) to Day 56 in Hamilton Anxiety Scale (HAM-A) Total Score.

  Baseline (Day 1) to Day 56

• Mean Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline (Day1) to Day 56.

  Baseline (Day1) to Day 56

Study Arms (1)

ANC-501

EXPERIMENTAL

50 mg/day

Drug: ANC-501

Interventions

ANC-501 DRUG

Five 10 mg capsules per day

ANC-501

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).
• 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.

Sponsors & Collaborators

• Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.: lead

Study Sites (8)

ATP Clinical Research

Orange, California, 92868, United States

Location

Florida Behavioral Medicine

Largo, Florida, 33770, United States

Location

Innovative Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

Location

Combined Research Orlando

Orlando, Florida, 32807, United States

Location

Clinilabs Drug Development Corporation

Eatontown, New Jersey, 07724, United States

Location

Clinilabs Drug development Corporation

New York, New York, 10016, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

Conrad Clinical Research

Edmond, Oklahoma, 73013, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Ancora Bio, Inc dba EmbarkNeuro

info@embarkneuro.com

610 871-4891

Study Officials

• Phil Perera, MD

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 30, 2022
• Study Start: September 19, 2022
• Primary Completion: August 14, 2023
• Study Completion: October 18, 2023
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2023-02

Locations

US (8)