NCT06786624

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 major-depressive-disorder

Timeline
14mo left

Started Jan 2025

Typical duration for phase_3 major-depressive-disorder

Geographic Reach
1 country

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jan 2025Jul 2027

First Submitted

Initial submission to the registry

January 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 22, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

October 29, 2025

Status Verified

October 1, 2025

Enrollment Period

2.4 years

First QC Date

January 15, 2025

Last Update Submit

October 28, 2025

Conditions

Major Depressive Disorder

Keywords

MDDDepressionMajor Depressive DisorderNBI-1065845TAK-653MADRS

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56

    Baseline, Day 56

Secondary Outcomes (2)

  • Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56

    Baseline, Day 56

  • Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56

    Baseline, Day 56

Study Arms (2)

NBI-1065845

EXPERIMENTAL

NBI-1065845 administered orally once a day.

Drug: NBI-1065845

Placebo

PLACEBO COMPARATOR

Placebo identical in appearance to NBI-1065845 will be administered orally once a day.

Drug: Placebo

Interventions

NBI-1065845DRUG

NBI-1065845 tablets

Also known as: TAK-653
NBI-1065845
PlaceboDRUG

Matching placebo tablets

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Neurocrine Clinical Site

Little Rock, Arkansas, 72204, United States

RECRUITING

Neurocrine Clinical Site

Garden Grove, California, 92844, United States

COMPLETED

Neurocrine Clinical Site

Orange, California, 92866, United States

RECRUITING

Neurocrine Clinical Site

Pico Rivera, California, 90660, United States

RECRUITING

Neurocrine Clinical Site

San Diego, California, 92103, United States

RECRUITING

Neurocrine Clinical Site

Upland, California, 91786, United States

RECRUITING

Neurocrine Clinical Site

Hollywood, Florida, 33024, United States

RECRUITING

Neurocrine Clinical Site

Maitland, Florida, 32751, United States

RECRUITING

Neurocrine Clinical Site

Boston, Massachusetts, 02116, United States

RECRUITING

Neurocrine Clinical Site

Watertown, Massachusetts, 02472, United States

SUSPENDED

Neurocrine Clinical Site

Mount Kisco, New York, 10549, United States

RECRUITING

Neurocrine Clinical Site

Avon Lake, Ohio, 44012, United States

RECRUITING

Neurocrine Clinical Site

Westlake, Ohio, 44145, United States

COMPLETED

Neurocrine Clinical Site

Dallas, Texas, 75251, United States

RECRUITING

Neurocrine Clinical Site

Houston, Texas, 77030, United States

RECRUITING

Neurocrine Clinical Site

Richmond, Texas, 77407, United States

WITHDRAWN

Neurocrine Clinical Site

The Woodlands, Texas, 77381, United States

SUSPENDED

Neurocrine Clinical Site

Everett, Washington, 98201, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Clinical Development Lead

    Neurocrine Biosciences

    STUDY DIRECTOR

Central Study Contacts

Neurocrine Medical Information Call Center

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 22, 2025

Study Start

January 22, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

October 29, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(18)