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

A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Who can join

Ages 18 and older · All sexes

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 prior to screening.
* 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.

Other protocol defined inclusion and exclusion criteria apply.

About the study

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

What is being tested

• NBI-1065845 (drug)

Sponsor: Neurocrine Biosciences · Participants: 850 · Started: Apr 16, 2025

Contact the study team

• Neurocrine Medical Information Call Center · Phone: 1-877-641-3461

Official record on ClinicalTrials.gov — NCT06966401

Locations in the U.S.

Conditions

• Major Depressive Disorder
• Depression

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.