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
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