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
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