Major Depressive DisorderPhase 3NCT06966401
Long-Term Study to Assess the Safety and Tolerability 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 120 sites in 23 countries.
Trial summary
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD. 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?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 120 sitesin 23 countries
- Study dates
- 16 Apr 2025to May 2030
- 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 prior to screening.
- 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.
- Other protocol defined inclusion and exclusion criteria apply.
Trial locations and contacts
120 sites in 23 countries. Contact the study team or a site near you to ask about taking part.
120 sites in 23 countries
United States49 sites, 43 recruiting
- Recruiting
Neurocrine Clinical Site
Atlanta, Georgia, 30318
- Recruiting
Neurocrine Clinical Site
Avon Lake, Ohio, 44012
- Withdrawn
Neurocrine Clinical Site
Bellaire, Texas, 77401
- Recruiting
Neurocrine Clinical Site
Boston, Massachusetts, 02116
- Recruiting
Neurocrine Clinical Site
Bryant, Arkansas, 72022
- Recruiting
Neurocrine Clinical Site
Cedarhurst, New York, 11516
- Recruiting
Neurocrine Clinical Site
Chino, California, 91710
- Recruiting
Neurocrine Clinical Site
Cromwell, Connecticut, 06416
- Recruiting
Neurocrine Clinical Site
Dallas, Texas, 75251
- Recruiting
Neurocrine Clinical Site
DeSoto, Texas, 75115
- Recruiting
Neurocrine Clinical Site
Draper, Utah, 84080
- Recruiting
Neurocrine Clinical Site
Edmond, Oklahoma, 73013
- Recruiting
Neurocrine Clinical Site
Farmington, Connecticut, 06030
- Recruiting
Neurocrine Clinical Site
Gaithersburg, Maryland, 20877
- Recruiting
Neurocrine Clinical Site
Glendale, California, 91206
- Recruiting
Neurocrine Clinical Site
Hollywood, Florida, 33024
- Recruiting
Neurocrine Clinical Site
Houston, Texas, 77030
- Recruiting
Neurocrine Clinical Site
Huntsville, Alabama, 35801
- Recruiting
Neurocrine Clinical Site
Irvine, California, 92614
- Recruiting
Neurocrine Clinical Site
Little Rock, Arkansas, 72204
- Recruiting
Neurocrine Clinical Site
Los Angeles, California, 90025
- Recruiting
Neurocrine Clinical Site
Maitland, Florida, 32751-5669
- Recruiting
Neurocrine Clinical Site
Maitland, Florida, 32751
- Recruiting
Neurocrine Clinical Site
Miami, Florida, 33174
- Recruiting
Neurocrine Clinical Site
Miami Gardens, Florida, 33014
- Recruiting
Neurocrine Clinical Site
Mount Kisco, New York, 10549
- Recruiting
Neurocrine Clinical Site
New York, New York, 10029
- Recruiting
Neurocrine Clinical Site
New York, New York, 10128
- Recruiting
Neurocrine Clinical Site
O'Fallon, Missouri, 63368
- Recruiting
Neurocrine Clinical Site
Oceanside, California, 92056
- Withdrawn
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112
- Recruiting
Neurocrine Clinical Site
Orange, California, 92866
- Withdrawn
Neurocrine Clinical Site
Orlando, Florida, 32803
- Recruiting
Neurocrine Clinical Site
Palm Bay, Florida, 32905
- Recruiting
Neurocrine Clinical Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Neurocrine Clinical Site
Pico Rivera, California, 90660
- Withdrawn
Neurocrine Clinical Site
Richmond, Texas, 77407
- Recruiting
Neurocrine Clinical Site
Saint Charles, Missouri, 63304
- Recruiting
Neurocrine Clinical Site
San Diego, California, 92103-8229
- Active, not recruiting
Neurocrine Clinical Site
San Francisco, California, 94107
- Recruiting
Neurocrine Clinical Site
San Jose, California, 95124
- Recruiting
Neurocrine Clinical Site
Stafford, Texas, 77477
- Recruiting
Neurocrine Clinical Site
Tampa, Florida, 33607
- Recruiting
Neurocrine Clinical Site
Tampa, Florida, 33613
- Recruiting
Neurocrine Clinical Site
Tampa, Florida, 33629
- Recruiting
Neurocrine Clinical Site
The Bronx, New York, 10461
- Recruiting
Neurocrine Clinical Site
The Woodlands, Texas, 77381
- Terminated
Neurocrine Clinical Site
Upland, California, 91786
- Recruiting
Neurocrine Clinical Site
Watertown, Massachusetts, 02472
Bulgaria9 sites, 6 recruiting
- Withdrawn
Neurocrine Clinical Site
Kardzhali, 6600
- Recruiting
Neurocrine Clinical Site
Plovdiv, 4400
- Withdrawn
Neurocrine Clinical Site
Rousse, 7003
- Recruiting
Neurocrine Clinical Site
Sofia, 1113
- Recruiting
Neurocrine Clinical Site
Sofia, 1408
- Withdrawn
Neurocrine Clinical Site
Sofia, 1510
- Recruiting
Neurocrine Clinical Site
Sofia, 1510
- Recruiting
Neurocrine Clinical Site
Sofia, 1680
- Recruiting
Neurocrine Clinical Site
Varna, 9020
Poland9 sites, 8 recruiting
- Recruiting
Neurocrine Clinical Site
Bełchatów, 97-400
- Recruiting
Neurocrine Clinical Site
Bialystok, 15-404
- Recruiting
Neurocrine Clinical Site
Bialystok, 15-756
- Withdrawn
Neurocrine Clinical Site
Bialystok, 15-879
- Recruiting
Neurocrine Clinical Site
Bydgoszcz, 85-794
- Recruiting
Neurocrine Clinical Site
Gdansk, 80-283
- Recruiting
Neurocrine Clinical Site
Gdansk, 80-546
- Recruiting
Neurocrine Clinical Site
Grudziądz, 86-300
- Recruiting
Neurocrine Clinical Site
Katowice, 40-514
Slovakia6 sites, 6 recruiting
- Recruiting
Neurocrine Clinical Site
Bojnice, 97201
- Recruiting
Neurocrine Clinical Site
Bratislava, 820 07
- Recruiting
Neurocrine Clinical Site
Košice, 04001
- Recruiting
Neurocrine Clinical Site
Rimavská Sobota, 979 01
- Recruiting
Neurocrine Clinical Site
Svidník, 089 01
- Recruiting
Neurocrine Clinical Site
Vranov nad Topľou, 093 01
Czechia5 sites, 5 recruiting
- Recruiting
Neurocrine Clinical Site
Pilsen, 30100
- Recruiting
Neurocrine Clinical Site
Prague, 100 00
- Recruiting
Neurocrine Clinical Site
Prague, 11000
- Recruiting
Neurocrine Clinical Site
Prague, 160 00
- Recruiting
Neurocrine Clinical Site
Prague, 186 00
United Kingdom4 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
London, SE5 8AF
- Withdrawn
Neurocrine Clinical Site
Manchester, M25 3BL
- Recruiting
Neurocrine Clinical Site
Sheffield, South Yorkshire, S3 7ND
- Withdrawn
Neurocrine Clinical Site
Southampton, Hampshire, SO30 3JB
Croatia3 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Zagreb, 10000
- Recruiting
Neurocrine Clinical Site
Zagreb, 10090
- Withdrawn
Neurocrine Clinical Site
Zagreb, 10090
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
Lithuania3 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Kaunas, LT-44279
- Recruiting
Neurocrine Clinical Site
Kaunas, LT-49449
- Recruiting
Neurocrine Clinical Site
Vilnius, LT-10309
Netherlands3 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Amsterdam, 1081 GN
- Recruiting
Neurocrine Clinical Site
Groningen, 9713 GZ
- Recruiting
Neurocrine Clinical Site
Leiden, 2333 ZA
Sweden3 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Gothenburg, 41345
- Recruiting
Neurocrine Clinical Site
Lund, 222 22
- Recruiting
Neurocrine Clinical Site
Stockholm, 113 29
Australia2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Carlton, Victoria, 3053
- Recruiting
Neurocrine Clinical Site
Melbourne, 3004
Belgium2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Alken, 3570
- Recruiting
Neurocrine Clinical Site
Mechelen, 2800
Canada2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
North Vancouver, British Columbia, V7P 2T4
- Recruiting
Neurocrine Clinical Site
Toronto, Ontario, M5H 1A1
Hungary2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Budapest, 1036
- Recruiting
Neurocrine Clinical Site
Budapest, 1135
Italy2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Milan, 20127
- Recruiting
Neurocrine Clinical Site
Roma, 00168
Serbia2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Belgrade, 11000
- Recruiting
Neurocrine Clinical Site
Kragujevac, 34000
South Korea2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Gyeonggi-do, 15355
- Recruiting
Neurocrine Clinical Site
Seoul, 03181
Spain2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Barcelona, 08025
- Recruiting
Neurocrine Clinical Site
Madrid, 28922
Taiwan2 sites, 1 recruiting
- Recruiting
Neurocrine Clinical Site
Keelung, 204
- Withdrawn
Neurocrine Clinical Site
Taipei, 112201
Romania1 site, 1 recruiting
- Recruiting
Neurocrine Clinical Site
Craiova, 200157
About this study
Official title: A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
- Conditions
- Major Depressive Disorder
- Being tested
- NBI-1065845
- Keywords
- MDD, Depression, Major Depressive Disorder, NBI-1065845, TAK-653
- 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
| Study group | Role | What they receive |
|---|---|---|
| NBI-1065845 | Experimental | NBI-1065845 administered orally once a day. Receives: Drug: NBI-1065845 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start16 Apr 2025
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 850 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
- NCT06966401
- Sponsor's protocol ID
- NBI-1065845-MDD3028
- Other IDs
- 2024-519423-24-00
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2025
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT06966401
- Acronym / sponsor ID
- NBI-1065845-MDD3028
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Depression, Major Depressive Disorder, NBI-1065845, TAK-653
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 11 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.
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBI-1065845 | Experimental | Drug: NBI-1065845NBI-1065845 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 (4 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 prior to screening.
- 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.
- Other protocol defined inclusion and exclusion criteria apply.
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 |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline through Week 52
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 2 Nov 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
120 sites in 23 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 120 sites in 23 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 4 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 120 sites in United States, Bulgaria, Poland, Slovakia, Czechia and 18 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. 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?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline through Week 52). 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 2 Nov 2026.