OpenComing Soon (1–3 yrs) Treatment Study
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
For Condition: Major Depressive Disorder
ID: NCT06786624
Horizon Patient Guidance Summary
Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:
How it’s taken
Pills / Oral Tablets
Expected Availability Horizon
Coming Soon (1–3 yrs away)
StageAdvanced Clinical Stage : Large-scale testing in thousands of patients. The final benchmark comparison phase closest to FDA approval and commercial release.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial
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.
Study Timeline & Quick Facts
Trial Status
Open — Looking for Participants
Total Target Enrollment
200 patients (Estimated)
Study Start Date
2025-01-22
Est. Primary Completion
2027-07
Tested Drugs & Treatment Groups
DRUGNBI-1065845
NBI-1065845 tablets
DRUGPlacebo
Matching placebo tablets
Treatment Arms Description
EXPERIMENTALNBI-1065845
NBI-1065845 administered orally once a day.
PLACEBO_COMPARATORPlacebo
Placebo identical in appearance to NBI-1065845 will be administered orally once a day.
Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
18 Years and older
Full Criteria Checklist
Who Can 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.
What is this Study Measuring?
Primary Outcome Measures
- Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56 — Time Frame: Baseline, Day 56
View Secondary Outcome Measures (2)
- Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56 — Time Frame: Baseline, Day 56
- Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56 — Time Frame: Baseline, Day 56
Where to Participate
This trial is recruiting at 18 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 18 Facilities & Contact Sites
Neurocrine Clinical Site
Little Rock, Arkansas, United States
Status: Open
Neurocrine Clinical Site
Garden Grove, California, United States
Status: Finished
Neurocrine Clinical Site
Orange, California, United States
Status: Open
Neurocrine Clinical Site
Pico Rivera, California, United States
Status: Open
Neurocrine Clinical Site
San Diego, California, United States
Status: Open
Neurocrine Clinical Site
Upland, California, United States
Status: Open
Neurocrine Clinical Site
Hollywood, Florida, United States
Status: Open
Neurocrine Clinical Site
Maitland, Florida, United States
Status: Open
Neurocrine Clinical Site
Boston, Massachusetts, United States
Status: Open
Neurocrine Clinical Site
Watertown, Massachusetts, United States
Status: Paused
Neurocrine Clinical Site
Mount Kisco, New York, United States
Status: Open
Neurocrine Clinical Site
Avon Lake, Ohio, United States
Status: Open
Neurocrine Clinical Site
Westlake, Ohio, United States
Status: Finished
Neurocrine Clinical Site
Dallas, Texas, United States
Status: Open
Neurocrine Clinical Site
Houston, Texas, United States
Status: Open
Neurocrine Clinical Site
Richmond, Texas, United States
Status: Withdrawn
Neurocrine Clinical Site
The Woodlands, Texas, United States
Status: Paused
Neurocrine Clinical Site
Everett, Washington, United States
Status: Open
Trial Design & Scientific Setup
Allocation
randomized
Intervention Model
parallel
Primary Purpose
treatment
Masking
quadruple (participant, care_provider, investigator, outcomes_assessor)
Sponsoring Teams & Contacts
Lead Sponsoring Institution
Neurocrine Biosciences
Primary Research Contact
Clinical Trial Application Copilot
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Subject: Inquiry about clinical trial enrollment: NCT06786624 - Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Dear Study Coordinator / Research Team,
I hope this message finds you well.
My name is [Your Name], and I am writing to express my strong interest in participating in the clinical trial titled "Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)" (NCT ID: NCT06786624).
I am [Age] years old and have been diagnosed with Major Depressive Disorder. I have reviewed the eligibility criteria for this study on Med Code Info and believe I may be a suitable candidate.
Could you please let me know if this study is actively enrolling patients at any site near my location, and what the next steps are to undergo screening?
Thank you for your time and research efforts.
Warm regards,
[Your Name]
View Official Medical/Scientific Title
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)