A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT ID: NCT07196501
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
550 participants
INTERVENTIONAL
2025-08-18
2028-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06963021
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06786624
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06911112
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06966401
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
NCT05203341
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Open-label Treatment Period: NBI-1065845
Participants will be treated with NBI-1065845 during the open-label treatment period.
NBI-1065845
Oral tablet
Randomized Double-blind Maintenance Period: NBI-1065845
Participants will be randomized to receive NBI-1065845 during the randomized double-blind maintenance period.
NBI-1065845
Oral tablet
Randomized Double-blind Maintenance Period: Placebo
Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period.
Placebo
Oral tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NBI-1065845
Oral tablet
Placebo
Oral tablet
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Neurocrine Biosciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurocrine Clinical Site
Oceanside, California, United States
Neurocrine Clinical Site
New Haven, Connecticut, United States
Neurocrine Clinical Site
Miami Gardens, Florida, United States
Neurocrine Clinical Site
Orlando, Florida, United States
Neurocrine Clinical Site
Palm Bay, Florida, United States
Neurocrine Clinical Site
Tampa, Florida, United States
Neurocrine Clinical Site
O'Fallon, Missouri, United States
Neurocrine Clinical Site
Albuquerque, New Mexico, United States
Neurocrine Clinical Site
Charlotte, North Carolina, United States
Neurocrine Clinical Site
Edmond, Oklahoma, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States
Neurocrine Clinical Site
Bellaire, Texas, United States
Neurocrine Clinical Site
Friendswood, Texas, United States
Neurocrine Clinical Site
Stafford, Texas, United States
Neurocrine Clinical Site
Wichita Falls, Texas, United States
Neurocrine Clinical Site
Draper, Utah, United States
Neurocrine Clinical Site
Sofia, , Bulgaria
Neurocrine Clinical Site
Sofia, , Bulgaria
Neurocrine Clinical Site
Sofia, , Bulgaria
Neurocrine Clinical Site
North Vancouver, British Columbia, Canada
Neurocrine Clinical Site
Sherbrooke, Quebec, Canada
Neurocrine Clinical Site
Toronto, , Canada
Neurocrine Clinical Site
Tallinn, , Estonia
Neurocrine Clinical Site
Tallinn, , Estonia
Neurocrine Clinical Site
Tartu, , Estonia
Neurocrine Clinical Site
Rome, , Italy
Neurocrine Clinical Site
Bialystok, , Poland
Neurocrine Clinical Site
Bydgoszcz, , Poland
Neurocrine Clinical Site
Gdansk, , Poland
Neurocrine Clinical Site
Barcelona, , Spain
Neurocrine Clinical Site
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-520541-72-00
Identifier Type: CTIS
Identifier Source: secondary_id
NBI-1065845-MDD3027
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.