Major Depressive DisorderPhase 3NCT07196501
A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Phase 3 study testing Osavampator in people with Major Depressive Disorder, run by Neurocrine Biosciences at 61 sites in 11 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of osavampator (previously NBI-1065845) compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) 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?
- Osavampator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 61 sitesin 11 countries
- Study dates
- 18 Aug 2025to Jul 2028
- 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.
- Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Trial locations and contacts
61 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
61 sites in 11 countries
United States24 sites, 20 recruiting
- Active, not recruiting
Neurocrine Clinical Site
Albuquerque, New Mexico, 87109
- Active, not recruiting
Neurocrine Clinical Site
Austin, Texas, 78712
- Recruiting
Neurocrine Clinical Site
Bellaire, Texas, 77401
- Recruiting
Neurocrine Clinical Site
Charlotte, North Carolina, 28211
- Recruiting
Neurocrine Clinical Site
Draper, Utah, 84020
- Recruiting
Neurocrine Clinical Site
Edmond, Oklahoma, 73013
- Terminated
Neurocrine Clinical Site
Friendswood, Texas, 77546
- Recruiting
Neurocrine Clinical Site
Glen Oaks, New York, 11004
- Recruiting
Neurocrine Clinical Site
Iowa City, Iowa, 52242
- Recruiting
Neurocrine Clinical Site
Marrero, Louisiana, 70072
- Recruiting
Neurocrine Clinical Site
Miami Gardens, Florida, 33014
- Recruiting
Neurocrine Clinical Site
New Haven, Connecticut, 06520
- Recruiting
Neurocrine Clinical Site
O'Fallon, Missouri, 63368
- Recruiting
Neurocrine Clinical Site
Oceanside, California, 92056
- Recruiting
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112
- Recruiting
Neurocrine Clinical Site
Orange, California, 92868
- Recruiting
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
Roanoke, Virginia, 24018
- Recruiting
Neurocrine Clinical Site
San Jose, California, 95124
- Recruiting
Neurocrine Clinical Site
Stafford, Texas, 77477
- Recruiting
Neurocrine Clinical Site
Tampa, Florida, 33629
- Active, not recruiting
Neurocrine Clinical Site
Wichita Falls, Texas, 76309
Canada5 sites, 4 recruiting
- Recruiting
Neurocrine Clinical Site
Calgary, Alberta, T2N 2T9
- Recruiting
Neurocrine Clinical Site
Kingston, Ontario, K7L 4X3
- Recruiting
Neurocrine Clinical Site
North Vancouver, British Columbia, V7P 2T4
- Active, not recruiting
Neurocrine Clinical Site
Sherbrooke, Quebec, J1L 0H8
- Recruiting
Neurocrine Clinical Site
Toronto, M5H 1A1
Bulgaria4 sites, 4 recruiting
- Recruiting
Neurocrine Clinical Site
Sofia, 1303
- Recruiting
Neurocrine Clinical Site
Sofia, 1408
- Recruiting
Neurocrine Clinical Site
Sofia, 1510
- Recruiting
Neurocrine Clinical Site
Sofia, 1680
Italy4 sites, 3 recruiting
- Withdrawn
Neurocrine Clinical Site
Milan, 20127
- Recruiting
Neurocrine Clinical Site
Roma, 168
- Recruiting
Neurocrine Clinical Site
Rome, 168
- Recruiting
Neurocrine Clinical Site
Torino, 10126
South Korea4 sites, 4 recruiting
- Recruiting
Neurocrine Clinical Site
Ansan-si, Gyeonggi-do, 15355
- Recruiting
Neurocrine Clinical Site
Seoul, 02841
- Recruiting
Neurocrine Clinical Site
Seoul, 06351
- Recruiting
Neurocrine Clinical Site
Seoul, 3181
Spain4 sites, 4 recruiting
- Recruiting
Neurocrine Clinical Site
Alcorcón, Madrid, 28922
- Recruiting
Neurocrine Clinical Site
Barcelona, 08025
- Recruiting
Neurocrine Clinical Site
Barcelona, 08035
- Recruiting
Neurocrine Clinical Site
Barcelona, 08036
Taiwan4 sites, 4 recruiting
- Recruiting
Neurocrine Clinical Site
Keelung, 204
- Recruiting
Neurocrine Clinical Site
Taipei, 10449
- Recruiting
Neurocrine Clinical Site
Taipei, 110
- Recruiting
Neurocrine Clinical Site
Taipei, 11217
Australia3 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Carlton, Victoria, 3053
- Recruiting
Neurocrine Clinical Site
Melbourne, Victoria, 3004
- Recruiting
Neurocrine Clinical Site
Parkville, Victoria, 3050
Estonia3 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Tallinn, 10138
- Recruiting
Neurocrine Clinical Site
Tallinn, 11315
- Recruiting
Neurocrine Clinical Site
Tartu, 50417
Poland3 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Bialystok, 15-879
- Recruiting
Neurocrine Clinical Site
Bydgoszcz, 85-794
- Recruiting
Neurocrine Clinical Site
Gdansk, 80-283
Serbia3 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Belgrade, 11000
- Recruiting
Neurocrine Clinical Site
Kovin, 26220
- Recruiting
Neurocrine Clinical Site
Kragujevac, 34000
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
The primary objective of this study is to evaluate the efficacy of osavampator (previously NBI-1065845) compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.
- Conditions
- Major Depressive Disorder
- Being tested
- Osavampator, Placebo
- Keywords
- Major Depressive Disorder, MDD, NBI-1065845
- 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.
OsavampatorDrug
Also called NBI-1065845
Oral tablet
PlaceboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Open-label Treatment Period: Osavampator | Experimental | Participants will be treated with osavampator during the open-label treatment period. Receives: Drug: Osavampator |
| Randomized Double-blind Maintenance Period: Osavampator | Experimental | Participants will be randomized to receive osavampator during the randomized double-blind maintenance period. Receives: Drug: Osavampator |
| Randomized Double-blind Maintenance Period: Placebo | Experimental | Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from Randomization to Relapse
Measured: From randomization to the earliest of relapse or end-of study (up to approximately 32 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start18 Aug 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 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 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
- 550 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
- NCT07196501
- Sponsor's protocol ID
- NBI-1065845-MDD3027
- Other IDs
- 2025-520541-72-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2025
- Last updated
- 22 Oct 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT07196501
- Acronym / sponsor ID
- NBI-1065845-MDD3027
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, MDD, NBI-1065845
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Sep 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 primary objective of this study is to evaluate the efficacy of osavampator (previously NBI-1065845) compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open-label Treatment Period: Osavampator | Experimental | Drug: OsavampatorParticipants will be treated with osavampator during the open-label treatment period. |
| Randomized Double-blind Maintenance Period: Osavampator | Experimental | Drug: OsavampatorParticipants will be randomized to receive osavampator during the randomized double-blind maintenance period. |
| Randomized Double-blind Maintenance Period: Placebo | Experimental | Drug: PlaceboParticipants will be randomized to receive matching placebo during the randomized double-blind maintenance period. |
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 (4 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.
- Note: Other protocol-defined Inclusion and Exclusion criteria may 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 |
|---|---|---|
| OsavampatorAlso: NBI-1065845Oral tablet | Drug | Open-label Treatment Period: Osavampator, Randomized Double-blind Maintenance Period: Osavampator |
| PlaceboOral tablet | Drug | Randomized Double-blind Maintenance Period: Placebo |
Primary outcome
Time from Randomization to Relapse
Time frame: From randomization to the earliest of relapse or end-of study (up to approximately 32 months)
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 22 Oct 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
61 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Osavampator in people with Major Depressive Disorder, run by Neurocrine Biosciences at 61 sites in 11 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 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Canada, Bulgaria, Italy, South Korea and 6 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?
Time from Randomization to Relapse (time frame: From randomization to the earliest of relapse or end-of study (up to approximately 32 months)). 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 22 Oct 2026.