Loading clinical trials...

NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

NBI-1065845-MDD3026: 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)

NCT06963021•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (16)

Neurocrine Clinical Site

Los Angeles, California, United States

Neurocrine Clinical Site

Aurora, Colorado, United States

Neurocrine Clinical Site

Cromwell, Connecticut, United States

Neurocrine Clinical Site

Farmington, Connecticut, United States

Neurocrine Clinical Site

Maitland, Florida, United States

Neurocrine Clinical Site

Tampa, Florida, United States

Neurocrine Clinical Site

Gaithersburg, Maryland, United States

Neurocrine Clinical Site

Cedarhurst, New York, United States

Neurocrine Clinical Site

New York, New York, United States

Neurocrine Clincial Site

New York, New York, United States

Key Dates

Start Date

May 30, 2025

Primary Completion Date

July 1, 2027

Completion Date

July 1, 2027

Last Updated

December 22, 2025

Enrollment

200

ESTIMATED participants

Conditions

Major Depressive Disorder

Interventions

NBI-1065845

DRUG

Placebo

DRUG

Contacts

Neurocrine Medical Information Call Center

CONTACT

1-877-641-3461 medinfo@neurocrine.com

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

View study

RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use