Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT ID: NCT06966401
Last Updated: 2025-08-01
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
600 participants
INTERVENTIONAL
2025-04-16
2030-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NBI-1065845
NBI-1065845 administered orally once a day.
NBI-1065845
NBI-1065845 tablets
Interventions
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NBI-1065845
NBI-1065845 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 prior to screening.
* 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.
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
Little Rock, Arkansas, United States
Neurocrine Clinical Site
Orange, California, United States
Neurocrine Clinical Site
Pico Rivera, California, United States
Neurocrine Clinical Site
Upland, California, United States
Neurocrine Clinical Site
Hollywood, Florida, United States
Neurocrine Clinical Site
Maitland, 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
Watertown, Massachusetts, United States
Neurocrine Clinical Site
Saint Charles, Missouri, United States
Neurocrine Clinical Site
Mount Kisco, New York, United States
Neurocrine Clinical Site
The Bronx, New York, United States
Neurocrine Clinical Site
Avon Lake, Ohio, United States
Neurocrine Clinical Site
Dallas, Texas, United States
Neurocrine Clinical Site
Richmond, Texas, United States
Neurocrine Clinical Site
The Woodlands, Texas, United States
Neurocrine Clinical Site
Everett, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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2024-519423-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
NBI-1065845-MDD3028
Identifier Type: -
Identifier Source: org_study_id
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