Recruiting

Phase 3

NBI-1065845A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Sponsor:

Neurocrine Biosciences

Code:

NCT07196501

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NBI-1065845

Placebo

Study Details

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.

Conditions

Major Depressive Disorder

Study ID

NCT07196501

Start date

Aug 18, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open-label Treatment Period: NBI-1065845

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

experimental: Randomized Double-blind Maintenance Period: NBI-1065845

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

experimental: Randomized Double-blind Maintenance Period: Placebo

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

Interventions

NBI-1065845

Oral tablet

Placebo

Oral tablet

Primary outcome measure

Time from Randomization to Relapse [ Time Frame: From randomization to the earliest of relapse or end-of study (up to approximately 32 months) ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

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

Locations

Neurocrine Clinical Site

Recruiting

Oceanside, California, United States, 92056

Neurocrine Clinical Site

Recruiting

Orange, California, United States, 92868

Neurocrine Clinical Site

Recruiting

San Jose, California, United States, 95124

Neurocrine Clinical Site

Recruiting

New Haven, Connecticut, United States, 06520

Neurocrine Clinical Site

Recruiting

Miami Gardens, Florida, United States, 33014

Neurocrine Clinical Site

Recruiting

Orlando, Florida, United States, 32803

Neurocrine Clinical Site

Recruiting

Palm Bay, Florida, United States, 32905

Neurocrine Clinical Site

Recruiting

Tampa, Florida, United States, 33629

Neurocrine Clinical Site

Recruiting

Iowa City, Iowa, United States, 52242

Neurocrine Clinical Site

Recruiting

Marrero, Louisiana, United States, 70072

Neurocrine Clinical Site

Recruiting

O'Fallon, Missouri, United States, 63368

Neurocrine Clinical Site

Recruiting

Albuquerque, New Mexico, United States, 87109

Neurocrine Clinical Site

Recruiting

Glen Oaks, New York, United States, 11004

Neurocrine Clinical Site

Recruiting

Charlotte, North Carolina, United States, 28211

Neurocrine Clinical Site

Recruiting

Edmond, Oklahoma, United States, 73013

Neurocrine Clinical Site

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Neurocrine Clinical Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Neurocrine Clinical Site

Recruiting

Bellaire, Texas, United States, 77401

Neurocrine Clinical Site

Recruiting

Stafford, Texas, United States, 77477

Neurocrine Clinical Site

Recruiting

Wichita Falls, Texas, United States, 76309

Neurocrine Clinical Site

Recruiting

Draper, Utah, United States, 84020

Neurocrine Clinical Site

Recruiting

Roanoke, Virginia, United States, 24018

Neurocrine Clinical Site

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Neurocrine Clinical Site

Recruiting

North Vancouver, British Columbia, Canada, V7P 2T4

Neurocrine Clinical Site

Recruiting

Kingston, Ontario, Canada, K7L 4X3

Neurocrine Clinical Site

Recruiting

Sherbrooke, Quebec, Canada, J1L 0H8

Neurocrine Clinical Site

Recruiting

Toronto, Canada, M5H 1A1

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

Major Depressive Disorder
MDD
NBI-1065845

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2026-07-24.