Major Depressive DisorderPhase 2NCT07772531
A Study to Evaluate BMS-986511 in Adults With Major Depressive Disorder
A Phase 2 study testing BMS-986511 in people with Major Depressive Disorder, run by Bristol-Myers Squibb at 27 sites in 2 countries.
Trial summary
A Study to Evaluate BMS-986511 in 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?
- BMS-986511
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 30 Oct 2026to 6 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participants must meet the MDD diagnosis per DSM-5 criteria confirmed by structured interview.
- Participant must have current moderate to severe MDE confirmed by clinical assessment and validated scale.
- Participant must have current MDE duration >12 weeks at screening.
- Outpatient participants able to comply with study procedures.
- Participant require medication washout completed before baseline.
- Participant must have BMI within protocol range.
- Participants must meet reproductive safety requirements.
Who cannot join
- Participants must not have other primary psychiatric disorders or a history of treatment-resistant depression during the current episode.
- Participants must not have recent history of active suicidal ideation or attempt within the past year.
- Participants must not have prior lifetime treatment with electroconvulsive therapy, ketamine/esketamine, deep brain stimulation, or transcranial magnetic stimulation.
- Participants must not have recent history of alcohol/substance abuse or use of cannabis.
- Participants must not have significant ECG abnormalities, or poorly controlled diabetes.
- Other protocol defined inclusion/exclusion criteria apply.
Trial locations and contacts
27 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
27 sites in 2 countries
United States21 sites
Local Institution - 0140
Atlanta, Georgia, 30331
Site 0140
Local Institution - 0075
Boston, Massachusetts, 02135
Site 0075
Local Institution - 0041
Cedarhurst, New York, 11516
Site 0041
Local Institution - 0083
Cincinnati, Ohio, 45219
Local Institution - 0086
Columbus, Ohio, 43210
Site 0086
Local Institution - 0016
Dallas, Texas, 75231
Site 0016
Local Institution - 0003
Everett, Washington, 98201
Site 0003
Local Institution - 0044
Gaithersburg, Maryland, 20877
Site 0044
Local Institution - 0046
Garden Grove, California, 92845
Site 0046
Local Institution - 0042
Glendale, California, 91206
Site 0042
Local Institution - 0007
Jacksonville, Florida, 32256
Site 0007
Local Institution - 0071
Lemon Grove, California, 91945
Site 0071
Local Institution - 0038
Little Rock, Arkansas, 72211
Site 0038
Local Institution - 0069
Mount Kisco, New York, 10549
Site 0069
Local Institution - 0079
Oakland, California, 94607
Site 0079
Local Institution - 0027
Oklahoma City, Oklahoma, 73116
Site 0027
Local Institution - 0024
Orlando, Florida, 32801
Site 0024
Local Institution - 0144
Phoenix, Arizona, 85012
Site 0144
Local Institution - 0047
Rogers, Arkansas, 72758
Site 0047
Local Institution - 0121
Staten Island, New York, 10312
Site 0121
Local Institution - 0050
Upland, California, 91786
Site 0050
Czechia6 sites
Local Institution - 0005
Kladno, 27201
Site 0005
Local Institution - 0081
Klecany, 25067
Site 0081
Local Institution - 0028
Pilsen, 31200
Site 0028
Local Institution - 0080
Prague, Czech Republic, 10000
Site 0080
Local Institution - 0111
Prague, Praha 6, 16000
Site 0111
Local Institution - 0032
Prague, Praha 8, 18600
Site 0032
About this study
Official title: A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of BMS-986511 in Two Sequential Parts in Participants With Major Depressive Disorder
A Study to Evaluate BMS-986511 in Adults with Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Being tested
- BMS-986511, Placebo
- Keywords
- Major Depressive Disorder, Depression, BMS-986511, Evifacotrep, TRPC4/5 Inhibitor, Antidepressant, Mood Disorders, Central Nervous System, MDD
- Medical subject headings
- Depressive Disorder, Major, Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986511Drug
Also called Evifacotrep
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986511: Dose A | Experimental | Not described Receives: Drug: BMS-986511 |
| BMS-986511: Dose B | Experimental | Not described Receives: Drug: BMS-986511 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in Hamilton Depression Rating Scale -17 Item (HDRS-17) total score
Measured: Up to Day 57
Secondary outcomes (4)
Number of Participants with Treatment Emergent Adverse Events (AEs)
Measured: Up to 71 days
Number of Participants with Serious Adverse Events (SAEs)
Measured: Up to 71 days
Number of Participants with AEs Leading to Treatment Discontinuation
Measured: Up to 71 days
Number of Participants with AEs Leading to Death
Measured: Up to Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start30 Oct 2026 (estimated)
- Primary completion6 Nov 2028 (estimated)
- Study completion6 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772531
- Sponsor's protocol ID
- CN013-0002
- Other IDs
- 2026-526617-28, U1111-1339-3799
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of BMS-986511 in Two Sequential Parts in Participants With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07772531
- Acronym / sponsor ID
- CN013-0002
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Depression, BMS-986511, Evifacotrep, TRPC4/5 Inhibitor, Antidepressant, Mood Disorders, Central Nervous System
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 6 Nov 2028 (estimated)
- Study completion
- 6 Nov 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Evaluate BMS-986511 in Adults with Major Depressive Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMS-986511: Dose A | Experimental | Drug: BMS-986511 |
| BMS-986511: Dose B | Experimental | Drug: BMS-986511 |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must meet the MDD diagnosis per DSM-5 criteria confirmed by structured interview.
- Participant must have current moderate to severe MDE confirmed by clinical assessment and validated scale.
- Participant must have current MDE duration >12 weeks at screening.
- Outpatient participants able to comply with study procedures.
- Participant require medication washout completed before baseline.
Key exclusion criteria (6 listed)
- Participants must not have other primary psychiatric disorders or a history of treatment-resistant depression during the current episode.
- Participants must not have recent history of active suicidal ideation or attempt within the past year.
- Participants must not have prior lifetime treatment with electroconvulsive therapy, ketamine/esketamine, deep brain stimulation, or transcranial magnetic stimulation.
- Participants must not have recent history of alcohol/substance abuse or use of cannabis.
- Participants must not have significant ECG abnormalities, or poorly controlled diabetes.
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 |
|---|---|---|
| BMS-986511Also: EvifacotrepSpecified dose on specified days | Drug | BMS-986511: Dose A, BMS-986511: Dose B |
| PlaceboSpecified dose on specified days | Drug | Placebo |
Primary outcome
Mean change from baseline in Hamilton Depression Rating Scale -17 Item (HDRS-17) total score
Time frame: Up to Day 57
4 secondary outcomes
Number of Participants with Treatment Emergent Adverse Events (AEs)
Time frame: Up to 71 days
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 71 days
Number of Participants with AEs Leading to Treatment Discontinuation
Time frame: Up to 71 days
Number of Participants with AEs Leading to Death
Time frame: Up to Day 71
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-986511 in people with Major Depressive Disorder, run by Bristol-Myers Squibb at 27 sites in 2 countries.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in Hamilton Depression Rating Scale -17 Item (HDRS-17) total score (time frame: Up to Day 57). 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 4 Sep 2026.