Major Depressive DisorderPhase 2NCT05439603
ANC-501 in the Treatment of Adults With Major Depressive Disorder
A Phase 2 study testing ANC-501 in people with Major Depressive Disorder, run by Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc. at 8 sites in United States.
Trial summary
A Phase 2 Study of ANC-501 in the treatment of adults with Major Depressive Disorder Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- ANC-501
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 8 sitesUnited States
- Study dates
- 19 Sep 2022to 18 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Clinilabs Drug Development Corporation
Eatontown, New Jersey, 07724
Conrad Clinical Research
Edmond, Oklahoma, 73013
Florida Behavioral Medicine
Largo, Florida, 33770
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Clinilabs Drug development Corporation
New York, New York, 10016
ATP Clinical Research
Orange, California, 92868
Combined Research Orlando
Orlando, Florida, 32807
Richmond Behavioral Associates
Staten Island, New York, 10314
About this study
Official title: 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
Read the 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)
- Conditions
- Major Depressive Disorder
- Being tested
- ANC-501
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANC-501Drug
Five 10 mg capsules per day
| Study group | Role | What they receive |
|---|---|---|
| ANC-501 | Experimental | 50 mg/day Receives: Drug: ANC-501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: Baseline (Day1) to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start19 Sep 2022
- Primary completion14 Aug 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phil Perera, MD, Study director, Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439603
- Sponsor's protocol ID
- ANC501D0005
- Status last verified
- Feb 2023
- First submitted
- 21 Jun 2022
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of ANC-501 in the Treatment of Adults With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05439603
- Acronym / sponsor ID
- ANC501D0005
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Posted 31 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANC-501 | Experimental | Drug: ANC-50150 mg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANC-501Five 10 mg capsules per day | Drug | ANC-501 |
Primary outcome
Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
Time frame: Baseline (Day 1) to Day 56
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.
7 secondary outcomes
Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 1) to Day 56
Mean Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline (Day1) to Day 56.
Time frame: Baseline (Day1) to Day 56
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement
Time frame: 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
Time frame: Baseline (Day1) to Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phil Perera, MD study director
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANC-501 in people with Major Depressive Disorder, run by Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. (time frame: Baseline (Day 1) to Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.