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RECRUITING
NCT06911112
PHASE3

NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Sponsor: Neurocrine Biosciences

View on ClinicalTrials.gov

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.

Official 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-03-31

Completion Date

2027-07

Last Updated

2026-08-11

Healthy Volunteers

No

Interventions

DRUG

NBI-1065845

NBI-1065845 tablets

DRUG

Placebo

Matching placebo tablets

Locations (39)

Neurocrine Clinical Site

Huntsville, Alabama, United States

Neurocrine Clinical Site

Bryant, Arkansas, United States

Neurocrine Clinical Site

Glendale, California, United States

Neurocrine Clinical Site

Irvine, California, United States

Neurocrine Clinical Site

Redlands, California, United States

Neurocrine Clinical Site

San Francisco, California, United States

Neurocrine Clinical Site

Hollywood, Florida, United States

Neurocrine Clinical Site

Miami, 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

Saint Charles, Missouri, United States

Neurocrine Clinical Site

New York, New York, United States

Neurocrine Clinical Site

The Bronx, New York, United States

Neurocrine Clinical Site

Mason, Ohio, United States

Neurocrine Clinical Site

DeSoto, Texas, United States

Neurocrine Clinical Site

Charlottesville, Virginia, United States

Neurocrine Clinical Site

Kardzhali, Bulgaria

Neurocrine Clinical Site

Plovdiv, Bulgaria

Neurocrine Clinical Site

Rousse, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Varna, Bulgaria

Neurocrine Clinical Site

Kaunas, Lithuania

Neurocrine Clinical Site

Kaunas, Lithuania

Neurocrine Clinical Site

Kaunas, Lithuania

Neurocrine Clinical Site

Klaipėda, Lithuania

Neurocrine Clinical Site

Vilnius, Lithuania

Neurocrine Clinical Site

Bucharest, Romania

Neurocrine Clinical Site

Bucharest, Romania

Neurocrine Clinical Site

Craiova, Romania

Neurocrine Clinical Site

Oradea, Romania

Neurocrine Clinical Site

Banská Bystrica, Slovakia

Neurocrine Clinical Site

Bojnice, Slovakia

Neurocrine Clinical Site

Bratislava, Slovakia

Neurocrine Clinical Site

Košice, Slovakia

Neurocrine Clinical Site

Rimavská Sobota, Slovakia

Neurocrine Clinical Site

Svidník, Slovakia

Neurocrine Clinical Site

Vranov nad Topľou, Slovakia