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

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: NBI-1065845; Drug: Placebo

• Registration Number: NCT07196501
• Lead Sponsor: Neurocrine Biosciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-18
• Status Verified: 2025-09
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Primary Completion: 2028-07
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open-label Treatment Period: NBI-1065845	NBI-1065845	Participants will be treated with NBI-1065845 during the open-label treatment period.
Randomized Double-blind Maintenance Period: NBI-1065845	NBI-1065845	Participants will be randomized to receive NBI-1065845 during the randomized double-blind maintenance period.
Randomized Double-blind Maintenance Period: Placebo	Placebo	Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period.

Primary Outcome Measures

Name	Time	Method
Time from Randomization to Relapse	From randomization to the earliest of relapse or end-of study (up to approximately 32 months)

Trial Locations

Locations (1)

Neurocrine Clinical Site; 🇺🇸 Friendswood, Texas, United States