NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
2 other identifiers
interventional
200
1 country
10
Brief Summary
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Mar 2025
Typical duration for phase_3 major-depressive-disorder
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2025
CompletedStudy Start
First participant enrolled
March 31, 2025
CompletedFirst Posted
Study publicly available on registry
April 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
December 1, 2025
November 1, 2025
2.3 years
March 28, 2025
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
Baseline, Day 56
Secondary Outcomes (2)
Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56
Baseline, Day 56
Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56
Baseline, Day 56
Study Arms (2)
NBI-1065845
EXPERIMENTALNBI-1065845 administered orally once a day.
Placebo
PLACEBO COMPARATORPlacebo identical in appearance to NBI-1065845 will be administered orally once a day.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Neurocrine Clinical Site
Huntsville, Alabama, 35801, United States
Neurocrine Clinical Site
Glendale, California, 91206, United States
Neurocrine Clinical Site
Irvine, California, 92614, United States
Neurocrine Clinical Site
Miami, Florida, 33174, United States
Neurocrine Clinical Site
Tampa, Florida, 33607, United States
Neurocrine Clinical Site
Atlanta, Georgia, 30318, United States
Neurocrine Clinical Site
Boston, Massachusetts, 02131, United States
Neurocrine Clinical Site
Saint Charles, Missouri, 63304, United States
Neurocrine Clinical Site
The Bronx, New York, 10461, United States
Neurocrine Clinical Site
Mason, Ohio, 45040, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Lead
Neurocrine Biosciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2025
First Posted
April 4, 2025
Study Start
March 31, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
December 1, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share