NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT ID: NCT06911112
Last Updated: 2025-12-01
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
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2025-03-31
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NBI-1065845
NBI-1065845 administered orally once a day.
NBI-1065845
NBI-1065845 tablets
Placebo
Placebo identical in appearance to NBI-1065845 will be administered orally once a day.
Placebo
Matching placebo tablets
Interventions
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NBI-1065845
NBI-1065845 tablets
Placebo
Matching placebo tablets
Other Intervention Names
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Eligibility Criteria
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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
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Neurocrine Clinical Site
Huntsville, Alabama, United States
Neurocrine Clinical Site
Glendale, California, United States
Neurocrine Clinical Site
Irvine, California, United States
Neurocrine Clinical Site
Miami, Florida, United States
Neurocrine Clinical Site
Tampa, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Boston, Massachusetts, United States
Neurocrine Clinical Site
Saint Charles, Missouri, United States
Neurocrine Clinical Site
The Bronx, New York, United States
Neurocrine Clinical Site
Mason, Ohio, United States
Countries
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Central Contacts
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Other Identifiers
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NBI-1065845-MDD3025
Identifier Type: -
Identifier Source: org_study_id
2024-519420-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
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