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RecruitingPhase 3NCT06786624

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)

Sponsor

Neurocrine Biosciences

Enrollment

200 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called NBI-1065845 as an add-on treatment for people with major depressive disorder (MDD) who haven't gotten enough relief from their current antidepressant. Researchers want to see if adding this drug to existing medication works better than adding a placebo. **You may be eligible if...** - You have been diagnosed with recurrent major depressive disorder (moderate or severe) or persistent depressive disorder - Your current antidepressant has not been working well enough - You have been on the same antidepressant at the same dose for at least 8 weeks - You have a high depression score (HAM-D17 of 22 or more) - You are willing to continue your current antidepressant throughout the study **You may NOT be eligible if...** - You have a different primary psychiatric diagnosis - Your depression has responded adequately to current medication - You are unable to commit to the study schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNBI-1065845

NBI-1065845 tablets

DRUGPlacebo

Matching placebo tablets

Locations(18)

Neurocrine Clinical Site

Little Rock, Arkansas, United States

Neurocrine Clinical Site

Garden Grove, California, United States

Neurocrine Clinical Site

Orange, California, United States

Neurocrine Clinical Site

Pico Rivera, California, United States

Neurocrine Clinical Site

San Diego, 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

Boston, Massachusetts, United States

Neurocrine Clinical Site

Watertown, Massachusetts, United States

Neurocrine Clinical Site

Mount Kisco, New York, United States

Neurocrine Clinical Site

Avon Lake, Ohio, United States

Neurocrine Clinical Site

Westlake, Ohio, United States

Neurocrine Clinical Site

Dallas, Texas, United States

Neurocrine Clinical Site

Houston, 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

View Full Details on ClinicalTrials.gov

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NCT06786624

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