NCT07196501

Brief 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.

Trial Health

88
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P50-P75 for phase_3 major-depressive-disorder

Timeline
26mo left

Started Aug 2025

Typical duration for phase_3 major-depressive-disorder

Geographic Reach
10 countries

42 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 Progress27%
Aug 2025Jul 2028

Study Start

First participant enrolled

August 18, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 19, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

March 19, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

September 19, 2025

Last Update Submit

March 17, 2026

Conditions

Major Depressive Disorder

Keywords

Major Depressive DisorderMDDNBI-1065845

Outcome Measures

Primary Outcomes (1)

  • Time from Randomization to Relapse

    From randomization to the earliest of relapse or end-of study (up to approximately 32 months)

Study Arms (3)

Open-label Treatment Period: NBI-1065845

EXPERIMENTAL

Participants will be treated with NBI-1065845 during the open-label treatment period.

Drug: NBI-1065845

Randomized Double-blind Maintenance Period: NBI-1065845

EXPERIMENTAL

Participants will be randomized to receive NBI-1065845 during the randomized double-blind maintenance period.

Drug: NBI-1065845

Randomized Double-blind Maintenance Period: Placebo

EXPERIMENTAL

Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period.

Drug: Placebo

Interventions

NBI-1065845DRUG

Oral tablet

Open-label Treatment Period: NBI-1065845Randomized Double-blind Maintenance Period: NBI-1065845
PlaceboDRUG

Oral tablet

Randomized Double-blind Maintenance Period: 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 (45)

Neurocrine Clinical Site

Oceanside, California, 92056, United States

RECRUITING

Neurocrine Clinical Site

San Jose, California, 95124, United States

RECRUITING

Neurocrine Clinical Site

New Haven, Connecticut, 06520, United States

RECRUITING

Neurocrine Clinical Site

Miami Gardens, Florida, 33014, United States

RECRUITING

Neurocrine Clinical Site

Orlando, Florida, 32803, United States

RECRUITING

Neurocrine Clinical Site

Palm Bay, Florida, 32905, United States

RECRUITING

Neurocrine Clinical Site

Tampa, Florida, 33629, United States

RECRUITING

Neurocrine Clinical Site

Marrero, Louisiana, 70072, United States

RECRUITING

Neurocrine Clinical Site

O'Fallon, Missouri, 63368, United States

RECRUITING

Neurocrine Clinical Site

Albuquerque, New Mexico, 87109, United States

RECRUITING

Neurocrine Clinical Site

Charlotte, North Carolina, 28211, United States

RECRUITING

Neurocrine Clinical Site

Edmond, Oklahoma, 73013, United States

RECRUITING

Neurocrine Clinical Site

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Neurocrine Clinical Site

Bellaire, Texas, 77401, United States

RECRUITING

Neurocrine Clinical Site

Friendswood, Texas, 77546, United States

RECRUITING

Neurocrine Clinical Site

Stafford, Texas, 77477, United States

RECRUITING

Neurocrine Clinical Site

Wichita Falls, Texas, 76309, United States

RECRUITING

Neurocrine Clinical Site

Draper, Utah, 84020, United States

RECRUITING

Neurocrine Clinical Site

Carlton, Victoria, 3053, Australia

RECRUITING

Neurocrine Clinical Site

Sofia, 1303, Bulgaria

RECRUITING

Neurocrine Clinical Site

Sofia, 1408, Bulgaria

RECRUITING

Neurocrine Clinical Site

Sofia, 1510, Bulgaria

RECRUITING

Neurocrine Clinical Site

Sofia, 1680, Bulgaria

RECRUITING

Neurocrine Clinical Site

North Vancouver, British Columbia, V7P 2T4, Canada

RECRUITING

Neurocrine Clinical Site

Sherbrooke, Quebec, J1L 0H8, Canada

RECRUITING

Neurocrine Clinical Site

Toronto, M5H 1A1, Canada

RECRUITING

Neurocrine Clinical Site

Tallinn, 10138, Estonia

RECRUITING

Neurocrine Clinical Site

Tallinn, 11315, Estonia

RECRUITING

Neurocrine Clinical Site

Tartu, 50417, Estonia

RECRUITING

Neurocrine Clinical Site

Milan, 20127, Italy

RECRUITING

Neurocrine Clinical Site

Rome, 168, Italy

RECRUITING

Neurocrine Clinical Site

Bialystok, 15-879, Poland

RECRUITING

Neurocrine Clinical Site

Bydgoszcz, 85-794, Poland

RECRUITING

Neurocrine Clinical Site

Gdansk, 80-283, Poland

RECRUITING

Neurocrine Clinical Site

Belgrade, 11000, Serbia

RECRUITING

Neurocrine Clinical Site

Kovin, 26220, Serbia

RECRUITING

Neurocrine Clinical Site

Ansan-si, Gyeonggi-do, 15355, South Korea

RECRUITING

Neurocrine Clinical Site

Seoul, 02841, South Korea

RECRUITING

Neurocrine Clinical Site

Seoul, 06351, South Korea

RECRUITING

Neurocrine Clinical Site

Alcorcón, Madrid, 28922, Spain

RECRUITING

Neurocrine Clinical Site

Barcelona, 08035, Spain

RECRUITING

Neurocrine Clinical Site

Keelung, 204, Taiwan

RECRUITING

Neurocrine Clinical Site

Taipei, 10449, Taiwan

RECRUITING

Neurocrine Clinical Site

Taipei, 110, Taiwan

RECRUITING

Neurocrine Clinical Site

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

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
Masking Details
The study consists of a non-randomized open-label treatment period and a randomized double-blind maintenance period.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2025

First Posted

September 29, 2025

Study Start

August 18, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

March 19, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)PL(3)BU(4)KR(3)SE(2)AU(1)CA(3)ES(2)TW(4)US(18)