Clinical trial NCT05439603: ANC-501 in the Treatment of Adults With Major Depressive Disorder
Official title: A Phase 2 Study of ANC-501 in the Treatment of Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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)

Eligibility 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 \[SNRI\], 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.

Primary outcomes:
measure: Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
timeFrame: Baseline (Day 1) to Day 56
Secondary outcomes:
measure: Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints.
timeFrame: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70
measure: Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response.
timeFrame: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70
measure: Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission.
timeFrame: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70
measure: Mean Change From Baseline (Day 1) to Day 56 in Hamilton Anxiety Scale (HAM-A) Total Score.
timeFrame: Baseline (Day 1) to Day 56
measure: Mean Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline (Day1) to Day 56.
timeFrame: Baseline (Day1) to Day 56
measure: Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement
timeFrame: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70
measure: Number of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement
timeFrame: Baseline (Day1) to Day 56
Other outcomes:
Locations:
city: Orange
country: United States
facility: ATP Clinical Research
state: California
city: Largo
country: United States
facility: Florida Behavioral Medicine
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando
state: Florida
city: Eatontown
country: United States
facility: Clinilabs Drug Development Corporation
state: New Jersey
city: New York
country: United States
facility: Clinilabs Drug development Corporation
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Edmond
country: United States
facility: Conrad Clinical Research
state: Oklahoma
Study officials:
affiliation: Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
name: Phil Perera, MD
role: STUDY_DIRECTOR
References: