Phase 2
N=15
ANC-501 in the Treatment of Adults With Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05439603 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. — -17.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ANC-501 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. |
-17.5 | — |
| SECONDARY Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints. |
-11.9; -15.6; -18.6; -17.8; -17.5; -18.8 | — |
| SECONDARY Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response. |
6; 6; 8; 9; 7; 7 | — |
| SECONDARY Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission. |
2; 3; 4; 3; 2; 4 | — |
| SECONDARY Mean Change From Baseline (Day 1) to Day 56 in Hamilton Anxiety Scale (HAM-A) Total Score. |
-7.6 | — |
| SECONDARY Mean Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline (Day1) to Day 56. |
-2.3 | — |
| SECONDARY Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement |
6; 8; 10; 9; 9; 9 | — |
| SECONDARY Number of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement |
9 | — |
Summary
A Phase 2 Study of ANC-501 in the treatment of adults with Major Depressive Disorder
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT05439603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.