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

A Phase 2 Study of ANC-501 in the Treatment of Adults With Major Depressive Disorder

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: ANC-501

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 depressive disorder (MDD)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • ATP Clinical Research
  • Florida
    • Largo, Florida, United States, 33770
      • Florida Behavioral Medicine
    • Lauderhill, Florida, United States, 33319
      • Innovative Clinical Research, Inc.
    • Orlando, Florida, United States, 32807
      • Combined Research Orlando
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Clinilabs Drug Development Corporation
  • New York
    • New York, New York, United States, 10016
      • Clinilabs Drug Development Corporation
    • Staten Island, New York, United States, 10314
      • Richmond Behavioral Associates
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Conrad Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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], 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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANC-501; 50 mg/day	Drug: ANC-501; Five 10 mg capsules per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints.	The MADRS was utilized to assess 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 (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.	MADRS responder rate was defined as >=50% reduction in total score from Baseline (Day 1) to all time points. The MADRS consists of 10 questions, each rated on a 7-point scale, to stratify severity of depressive episodes. 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 (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.	MADRS remission rate was defined where total score was <=10 at all time points. The MADRS consists of 10 questions, each rated on a 7-point scale, to stratify severity of depressive episodes. 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 (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.	The HAM-A was utilized as an assessment to rate participants level of anxiety. HAM-A is a 14-item questionnaire with each question rated on a 5-point scale with a total score of 0 to 56. The higher scores indicating more severe anxiety symptoms.	Baseline (Day 1) to Day 56
Mean Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline (Day1) to Day 56.	The CGI-S was utilized as an assessment for clinician to rate the severity of the patient's illness at the time of the assessment, relative to past experience with patients having the same diagnosis. CGI-S is a 7-point scale with response choices included: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The response at Day 56 was compared with the participants condition at Baseline prior to the first dose of study medication.	Baseline (Day1) to Day 56
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement	The CGI-I was utilized as an assessment for clinician to rate the improvement of the patient's illness at the time of the assessment compared to patient's condition at admission of the trial. To perform this assessment, the study physician answered the following question: "Compared to his/her condition at admission to the project, how much has he/she changed?" This question is rated on a scale from 0 to 7, where a higher score indicates greater lack of improvement. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given visit was compared with the participants condition at Baseline prior to the first dose of study medication. A CGI-I improver was defined as a subject with a CGI-I score of "Very much approved" or "Much Approved".	Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement	The CGI-I was utilized as an assessment for clinician to rate the improvement of the patient's illness at the time of the assessment compared to patient's condition at admission of the trial. To perform this assessment, the study physician answered the following question: "Compared to his/her condition at admission to the project, how much has he/she changed?" This question is rated on a scale from 0 to 7, where a higher score indicates greater lack of improvement. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a Day 56 was compared with the participants condition at Baseline prior to the first dose of study medication. A CGI-I improver was defined as a subject with a CGI-I score of "Very much approved" or "Much Approved".	Baseline (Day1) to Day 56

Collaborators and Investigators

• Sponsor: Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
• Investigators: Study Director: Phil Perera, MD, Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: ANC501D0005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No