Long-Term Study to Assess the Safety and Tolerability 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06966401

2024-519423-24-00 (EU Trial (CTIS) Number)

NBI-1065845-MDD3028

Details and patient eligibility

About

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

Enrollment: 600 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 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

NBI-1065845

Experimental group

Description:

NBI-1065845 administered orally once a day.

Treatment:

Drug: NBI-1065845