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

October 28, 2025 updated by: Neurocrine Biosciences

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Neurocrine Clinical Site
    • California
      • Garden Grove, California, United States, 92844
        • Completed
        • Neurocrine Clinical Site
      • Orange, California, United States, 92866
        • Recruiting
        • Neurocrine Clinical Site
      • Pico Rivera, California, United States, 90660
        • Recruiting
        • Neurocrine Clinical Site
      • San Diego, California, United States, 92103
        • Recruiting
        • Neurocrine Clinical Site
      • Upland, California, United States, 91786
        • Recruiting
        • Neurocrine Clinical Site
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Neurocrine Clinical Site
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Neurocrine Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Recruiting
        • Neurocrine Clinical Site
      • Watertown, Massachusetts, United States, 02472
        • Suspended
        • Neurocrine Clinical Site
    • New York
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Neurocrine Clinical Site
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Recruiting
        • Neurocrine Clinical Site
      • Westlake, Ohio, United States, 44145
        • Completed
        • Neurocrine Clinical Site
    • Texas
      • Dallas, Texas, United States, 75251
        • Recruiting
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Neurocrine Clinical Site
      • Richmond, Texas, United States, 77407
        • Withdrawn
        • Neurocrine Clinical Site
      • The Woodlands, Texas, United States, 77381
        • Suspended
        • Neurocrine Clinical Site
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NBI-1065845
NBI-1065845 administered orally once a day.
Drug: NBI-1065845
NBI-1065845 tablets
Other Names:
  • TAK-653
Placebo Comparator: Placebo
Placebo identical in appearance to NBI-1065845 will be administered orally once a day.
Drug: Placebo
Matching placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
Time Frame: Baseline, Day 56
Baseline, Day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56
Time Frame: Baseline, Day 56
Baseline, Day 56
Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56
Time Frame: Baseline, Day 56
Baseline, Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-1065845-MDD3024
  • 2024-519418-29-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe