RecruitingPhase 3NCT07196501

A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Sponsor

Neurocrine Biosciences

Enrollment

550 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

Summary

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new add-on medication called NBI-1065845 for people with major depression who haven't responded well enough to their current antidepressant. It focuses on whether the drug can help maintain improvement over the long term. **You may be eligible if...** - You have been diagnosed with recurring or persistent major depression (moderate or severe) - Your current antidepressant isn't working well enough - You have been on the same antidepressant for at least 8 weeks and are willing to continue it - Your depression symptoms score above a certain threshold on a standard rating scale **You may NOT be eligible if...** - You have another major psychiatric condition diagnosed in the past year - You are not willing or able to follow the study requirements - You have certain medical conditions that could interfere with the study medication 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNBI-1065845

Oral tablet

DRUGPlacebo

Oral tablet

Locations(45)

Neurocrine Clinical Site

Oceanside, California, United States

Neurocrine Clinical Site

San Jose, California, United States

Neurocrine Clinical Site

New Haven, Connecticut, United States

Neurocrine Clinical Site

Miami Gardens, Florida, United States

Neurocrine Clinical Site

Orlando, Florida, United States

Neurocrine Clinical Site

Palm Bay, Florida, United States

Neurocrine Clinical Site

Tampa, Florida, United States

Neurocrine Clinical Site

Marrero, Louisiana, United States

Neurocrine Clinical Site

O'Fallon, Missouri, United States

Neurocrine Clinical Site

Albuquerque, New Mexico, United States

Neurocrine Clinical Site

Charlotte, North Carolina, United States

Neurocrine Clinical Site

Edmond, Oklahoma, United States

Neurocrine Clinical Site

Oklahoma City, Oklahoma, United States

Neurocrine Clinical Site

Bellaire, Texas, United States

Neurocrine Clinical Site

Friendswood, Texas, United States

Neurocrine Clinical Site

Stafford, Texas, United States

Neurocrine Clinical Site

Wichita Falls, Texas, United States

Neurocrine Clinical Site

Draper, Utah, United States

Neurocrine Clinical Site

Carlton, Victoria, Australia

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

North Vancouver, British Columbia, Canada

Neurocrine Clinical Site

Sherbrooke, Quebec, Canada

Neurocrine Clinical Site

Toronto, Canada

Neurocrine Clinical Site

Tallinn, Estonia

Neurocrine Clinical Site

Tallinn, Estonia

Neurocrine Clinical Site

Tartu, Estonia

Neurocrine Clinical Site

Milan, Italy

Neurocrine Clinical Site

Rome, Italy

Neurocrine Clinical Site

Bialystok, Poland

Neurocrine Clinical Site

Bydgoszcz, Poland

Neurocrine Clinical Site

Gdansk, Poland

Neurocrine Clinical Site

Belgrade, Serbia

Neurocrine Clinical Site

Kovin, Serbia

Neurocrine Clinical Site

Ansan-si, Gyeonggi-do, South Korea

Neurocrine Clinical Site

Seoul, South Korea

Neurocrine Clinical Site

Seoul, South Korea

Neurocrine Clinical Site

Alcorcón, Madrid, Spain

Neurocrine Clinical Site

Barcelona, Spain

Neurocrine Clinical Site

Keelung, Taiwan

Neurocrine Clinical Site

Taipei, Taiwan

Neurocrine Clinical Site

Taipei, Taiwan

Neurocrine Clinical Site

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07196501

Related Trials

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine

NCT071858156 locations

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

NCT058927441 location

A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(45)

Related Trials

Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

CARED : A Novel Rapid Treatment Paradigm for Depression

Natural History of Depression, Bipolar Disorder and Suicide Risk

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression