Major Depressive DisorderPhase 3NCT06963021
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Phase 3 study testing NBI-1065845 in people with Major Depressive Disorder, run by Neurocrine Biosciences at 35 sites in 7 countries.
Trial summary
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- NBI-1065845
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 35 sitesin 7 countries
- Study dates
- 30 May 2025to Jul 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
- Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
- Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
- Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
Who cannot join
- A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
- Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
- Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
Trial locations and contacts
35 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 7 countries
United States15 sites, 10 recruiting
- Recruiting
Neurocrine Clinical Site
Aurora, Colorado, 80045
- Recruiting
Neurocrine Clinical Site
Cedarhurst, New York, 11516
- Recruiting
Neurocrine Clinical Site
Charlotte, North Carolina, 28211
- Recruiting
Neurocrine Clinical Site
Chino, California, 91710
- Active, not recruiting
Neurocrine Clinical Site
Cromwell, Connecticut, 06416
- Active, not recruiting
Neurocrine Clinical Site
Farmington, Connecticut, 06030
- Active, not recruiting
Neurocrine Clinical Site
Gaithersburg, Maryland, 20877
- Recruiting
Neurocrine Clinical Site
Los Angeles, California, 90025
- Recruiting
Neurocrine Clinical Site
Maitland, Florida, 32751
- Recruiting
Neurocrine Clinical Site
Miami, Florida, 33136
- Active, not recruiting
Neurocrine Clinical Site
New York, New York, 10029
- Recruiting
Neurocrine Clinical Site
New York, New York, 10128
- Recruiting
Neurocrine Clinical Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Neurocrine Clinical Site
Stanford, California, 94305
- Withdrawn
Neurocrine Clinical Site
Tampa, Florida, 33613
Hungary5 sites, 4 recruiting
- Recruiting
Neurocrine Clinical Site
Budapest, 1036
- Recruiting
Neurocrine Clinical Site
Budapest, 1083
- Recruiting
Neurocrine Clinical Site
Budapest, 1135
- Recruiting
Neurocrine Clinical Site
Gyöngyös, 3200
- Active, not recruiting
Neurocrine Clinical Site
Kalocsa, 6300
United Kingdom4 sites, 4 recruiting
- Recruiting
Neurocrine Clinical Site
London, SE5 8AZ
- Recruiting
Neurocrine Clinical Site
Salford, M6 8HD
- Recruiting
Neurocrine Clinical Site
Sheffield, S5 7JT
- Recruiting
Neurocrine Clinical Site
Southampton, SO30 3JB
Belgium3 sites, 2 recruiting
- Active, not recruiting
Neurocrine Clinical Site
Alken, 3570
- Recruiting
Neurocrine Clinical Site
Bruges, 8310
- Recruiting
Neurocrine Clinical Site
Mechelen, 2800
Finland3 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Kuopio, 70110
- Recruiting
Neurocrine Clinical Site
Oulu, 90100
- Recruiting
Neurocrine Clinical Site
Tampere, 33210
Latvia3 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Jelgava, LV-3008
- Recruiting
Neurocrine Clinical Site
Liepāja, LV-3401
- Recruiting
Neurocrine Clinical Site
Sigulda, LV-2150
Canada2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Toronto, Ontario, M5B 1W8
- Recruiting
Neurocrine Clinical Site
Verdun, H4H 1R3
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
- Conditions
- Major Depressive Disorder
- Being tested
- NBI-1065845, Placebo
- Keywords
- MDD, Depression, Major Depressive Disorder, NBI-1065845, TAK-653, MADRS
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-1065845Drug
Also called TAK-653
NBI-1065845 tablets
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| NBI-1065845 | Experimental | NBI-1065845 administered orally once a day. Receives: Drug: NBI-1065845 |
| Placebo | Placebo comparator | Placebo identical in appearance to NBI-1065845 will be administered orally once a day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
Measured: Baseline, Day 56
Secondary outcomes (2)
Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56
Measured: Baseline, Day 56
Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56
Measured: Baseline, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start30 May 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (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 Neurocrine BiosciencesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963021
- Sponsor's protocol ID
- NBI-1065845-MDD3026
- Other IDs
- 2024-519421-37-00
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT06963021
- Acronym / sponsor ID
- NBI-1065845-MDD3026
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Depression, Major Depressive Disorder, NBI-1065845, TAK-653, MADRS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 30 May 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 May 2025 (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.
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBI-1065845 | Experimental | Drug: NBI-1065845NBI-1065845 administered orally once a day. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo identical in appearance to NBI-1065845 will be administered orally once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
- Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
- Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
- Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
Key exclusion criteria (3 listed)
- A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
- Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
- Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
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 |
|---|---|---|
| NBI-1065845Also: TAK-653NBI-1065845 tablets | Drug | NBI-1065845 |
| PlaceboMatching placebo tablets | Drug | Placebo |
Primary outcome
Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
Time frame: Baseline, Day 56
2 secondary outcomes
Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56
Time frame: Baseline, Day 56
Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56
Time frame: Baseline, Day 56
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Clinical Development Lead study director
Neurocrine Biosciences
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NBI-1065845 in people with Major Depressive Disorder, run by Neurocrine Biosciences at 35 sites in 7 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Hungary, United Kingdom, Belgium, Finland and 2 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Neurocrine Medical Information Call Center (1-877-641-3461, medinfo@neurocrine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56 (time frame: Baseline, 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 10 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.