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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05439603
• Other study ID #: ANC501D0005
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 19, 2022
• Est. completion date: November 25, 2023

Study information

• Verified date: February 2023
• Source: Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 25, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• ANC-501
Five 10 mg capsules per day

Locations

Country	Name	City	State
United States	Clinilabs Drug Development Corporation	Eatontown	New Jersey
United States	Conrad Clinical Research	Edmond	Oklahoma
United States	Florida Behavioral Medicine	Largo	Florida
United States	Innovative Clinical Research, Inc.	Lauderhill	Florida
United States	ATP Clinical Research	Orange	California
United States	Combined Research Orlando Phase I-IV	Orlando	Florida
United States	Richmond Behavioral Associates	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change from Baseline Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	To evaluate the effect of treatment with ANC-501 capsules on depressive symptoms in subjects with major depressive disorder (MDD)	Baseline (Day 1) to Day 56
Primary	Treatment-emergent Adverse Events	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	Baseline (Day 1) up to Day 112