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

Neurocrine Biosciences

Status and phase: Enrolling; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: NBI-1065845; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07196501

2025-520541-72-00 (EU Trial (CTIS) Number)

NBI-1065845-MDD3027

Details and patient eligibility

About

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.

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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550 participants in 3 patient groups

Open-label Treatment Period: NBI-1065845

Experimental group

Description:

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

Treatment:

Drug: NBI-1065845

Randomized Double-blind Maintenance Period: NBI-1065845

Experimental group

Description:

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

Treatment:

Drug: NBI-1065845

Randomized Double-blind Maintenance Period: Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo